Professional Documents
Culture Documents
OF ICD TECHNOLOGY
2017
CONCEPTS OF
ICD TECHNOLOGY
SENSING &
DETECTION
MAY 2017
DISCLOSURES
This presentation is provided for general educational purposes only and should not be
considered the exclusive source for this type of information. This training does not replace or
supersede approved labeling. The content will be shared with physicians and allied health
professionals who seek a deeper understanding of the operation and use of Medtronic
products and therapies with the intent of enhancing their knowledge of features and
operations described in the clinician manuals.
The device data presented in this module is fictional and is designed only for educational
purposes. At all times, it is the professional responsibility of the practitioner to exercise
independent clinical judgment in a particular situation. Changes in a patient’s disease and/or
medications may alter the efficacy of a device’s programmed parameters or related features
and results may vary. The device functionality and programming described in this
presentation are based on Medtronic products and can be referenced in the published device
manuals.
Important Reminder: This information is intended only for users in markets where Medtronic
products and therapies are approved or available for. Content on specific Medtronic products
and therapies is not intended for users in markets that do not have authorization for use.
The device functionality and programming described in this module can be found in some
Medtronic ICD and CRT-D devices. Please go to manuals.medtronic.com or consult with your
local Medtronic representative regarding device models available in your geography.
OBJECTIVES
1Glikson M, Friedman PA. The implantable cardioverter defibrillator. Lancet. April 7, 2001;357(9262):1107-1117.
2 EpsteinAE, DiMarco JP, Ellenbogen KA, et al. ACC/AHA/HRS 2008 Guidelines for device-based therapy of cardiac rhythm abnormalities [corrections
appear at J Am Coll Cardiol. April 21, 2009; 53(16):1473. J Am Coll Cardiol. January 6, 2009;53(1):147]. J Am Coll Cardiol. May 27, 2008;51(21):e1-
62.
THE ICD SYSTEM
IMPLANTED ICD
HEADER
BATTERY
CIRCUITRY
CAPACITOR
HOW HIGH VOLTAGE IS GENERATED
LEAD ELECTRICAL DESIGN
PACING AND SENSING CONFIGURATIONS
TRUE BIPOLAR
CONFIGURATION
INTEGRATED BIPOLAR
CONFIGURATION
Store diagnostics
SENSING
ICD SENSING
Amplifier Bandpass
Rectifier Threshold
Filter
Sensitivity setting
Ellenbogen KA, Wilkoff BL, Kay GN, Lau CP, Auricchio A. Clinical Cardiac Pacing, Defibrillation, and Resynchronization Therapy.
Philadelphia, PA: Elsevier Health Sciences; 2016.
A SENSING CHALLENGE
COMPLEX AND CHANGING MORPHOLOGIES
Normal Sinus
Rhythm
Ventricular
Tachycardia
VT
Ventricular
Fibrillation
VF
AUTO-ADJUSTING SENSITIVITY
RV TIP TO RV RING
True Bipolar
RV TIP TO RV COIL
Integrated Bipolar
CLASSIFYING SENSED BEATS
VENTRICULAR
SENSED BEAT
VENTRICULAR
PACED BEAT
DETECTION ZONES
Programmed VF Programmed VT
Detection Interval Detection Interval
(VFDI) (VTDI)
MARKER CHANNELS*
TS = Sensed Beat in
VT Detection Zone
TD = VT Detected
or Redetected
FS = Sensed Beat in
VF Detection Zone
FD= VF Detected or
Redetected
Ventricular Tachycardia
Regular intervals
Monomorphic
Less susceptible to
undersensing than VF
Ventricular Fibrillation
Irregular intervals
Polymorphic
More susceptible to
undersensing than VT
CONSECUTIVE COUNTER
VT ZONE
Counts consecutive intervals that fall within the programmed VT detection zone
Consecutive method makes VT detection very specific
Applies to the VT or Fast VT via VT zone
ECG
VF
Intervals
1 2 3 4 5 6 7 8 9 1011 12 1314 15 16 1718
1 2 3 4 5 6 7 8 910111213 14 15 16 17 18 19 20 21 22 23
Initial detection
Re-detection
Unsuccessful
shock
COMBINED COUNT
Combined Count is used when a rhythm fluctuates between the VT and VF zone.
COMBINED COUNT NID
OPERATION
VF
COUNTER
=6
COMBINE
D COUNT
NID
LOOK
BACK 8
BEATS
7/6 x VF beats to detect = 7/6 x 24 = 28
FAST VT ZONE
The Fast VT via VT zone can be used to allow for different therapies for
patients with 2 VTs of different rates.
Fast VT via VF zone can be used to detect and treat VT episodes that fall in
the VF zone.
CASE EXAMPLE
CASE EXAMPLE
This device feature allows for sensing of fine VF waves while preventing
sensing of T-waves, cross chamber events, and pacing artifacts.
A. Marker Channels
B. Programmable RV Sensing
C. Auto-adjusting sensitivity
D. None of the above
KNOWLEDGE CHECK
QUESTION 2
Is there appropriate
sensing observed in
this strip?
A. Yes
B. No
KNOWLEDGE CHECK
QUESTION 3
A. True Bipolar
B. Integrated Bipolar
C. RV tip to RV coil
D. RV tip to RV ring
KNOWLEDGE CHECK
QUESTION 4
A. FVT
B. VF
C. VT
D. VT Monitor
KNOWLEDGE CHECK
QUESTION 5
Given the detection windows shown below, which of the following zones
have been programmed:
A. VF
B. Monitored VT
C. VT
D. Fast VT
KNOWLEDGE CHECK
QUESTION 7
A. Probabilistic Counter
B. Consecutive Counter
C. Combined Counter
KNOWLEDGE CHECK
QUESTION 8
2017
DISCLOSURES
This presentation is provided for general educational purposes only and should not be
considered the exclusive source for this type of information. This training does not replace or
supersede approved labeling. The content will be shared with physicians and allied health
professionals who seek a deeper understanding of the operation and use of Medtronic
products and therapies with the intent of enhancing their knowledge of features and
operations described in the clinician manuals.
The device data presented in this module is fictional and is designed only for educational
purposes. At all times, it is the professional responsibility of the practitioner to exercise
independent clinical judgment in a particular situation. Changes in a patient’s disease and/or
medications may alter the efficacy of a device’s programmed parameters or related features
and results may vary. The device functionality and programming described in this
presentation are based on Medtronic products and can be referenced in the published device
manuals.
Important Reminder: This information is intended only for users in markets where Medtronic
products and therapies are approved or available for. Content on specific Medtronic products
and therapies is not intended for users in markets that do not have authorization for use.
The device functionality and programming described in this module can be found in some
Medtronic ICD and CRT-D devices. Please go to manuals.medtronic.com or consult with your
local Medtronic representative regarding device models available in your geography.
OBJECTIVES
BRADYARRHYTHMIA PACING
CARDIOVERSION
DEFIBRILLATION
CONFIRMATION
BRADYARRHYTHMIA
PACING
BRADYCARDIA
LOW POWER THERAPY
Low power bradycardia pacing in ICDs works the same way as in a pacemaker.
The device paces when the heart rate drops below the programmed lower rate or
AV conduction is lost. Pacing is also crucial after a shock is delivered in the
event that normal sinus rhythm takes time to restore.
ICD patients generally do not have a pacing indication and therefore the percent
of pacing should be minimized.1
MAIN
MENU
¹Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on heart failure and atrial fibrillation among patients with normal
baseline QRS duration in a clinical trial of pacemaker therapy for sinus node dysfunction. Circulation. 2003:107(23):2932-2937.
ANTITACHYCARDIA
PACING
(ATP)
ANTITACHYCARDIA PACING (ATP)
LOW POWER
Fast pacing pulses delivered to the heart through the lead to interrupt the
reentrant circuit of an arrhythmia
Provides pain free therapy
Different types available (i.e. Burst, Ramp)
HOW ATP THERAPY WORKS
INTRODUCTION
Unidirectional block
Overdrive pacing of the tissue in this Reentry circuit/loop
gap can stop the tachycardia. Excitable gap
HOW ATP THERAPY WORKS
A MORE DETAILED LOOK
ANTITACHYCARDIA PACING
RATE
T T T T T T T T T
S S S S D P P P P
Pulses (S1)
Initial
detection redetection redetection
redetection 280 280 280 280 redetection 270 270 270 270
330 ms 330 ms
2nd sequence 3rd sequence
R-R average R-R average
Rate of the 2nd pacing interval = 330 ms x 0.88 = Rate of the 3rd pacing interval = 330 ms x 0.88 =
* Decrement between sequences 290 ms – 10 ms decrement = 280 ms 290 ms – 20 ms decrement = 270 ms
ANTITACHYCARDIA PACING
RAMP
Rate of the first pacing interval = 350 ms x 0.91 = 320
ms
320 310 300 290 280 redetection 300 290 280 270 260250
redetection
FOR INFORMATION ON
PROGRAMMING ATP CLICK
HERE
WHEN SHOULD ATP BE PROGRAMMED?
2 Wathen MS, Sweeney MO, DeGroot PJ, et al. Shock Reduction using antitachycardia pacing for spontaneous rapid ventricular tachycardia in patients with coronary
artery disease. Circulation. 2001;104:796-801.
3 Wathen MS, DeGroot PJ, Sweeney MO, et al. Prospective randomized multicenter trial of empirical antitachycardia pacing versus shocks for spontaneous rapid
ventricular tachycardia in patients with implantable cardioverter-defibrillators. Pacing Fast Ventricular Tachycardiac Reduces Shock Therapies (PainFREE Rx II) trial
results. Circulation. 2004;110:2591-2596.
MARKERS CHANNELS
Decision Channels:*
Provides additional ICD detection
information
Stored on EGM Strip, or printed real-
time (not displayed on screen)
MAIN
*in Medtronic ICDs MENU
KNOWLEDGE CHECK
QUESTION 1 OF 8
The rate of the ATP pulses is dependent upon the cycle length of the
detected arrhythmia.
A. True
B. False
KNOWLEDGE CHECK
QUESTION 3 OF 8
A. Burst
B. Ramp
KNOWLEDGE CHECK
QUESTION 4 OF 8
A. Burst
B. Ramp
MAIN
MENU
CARDIOVERSION
CV
CARDIOVERSION (CV) – HIGH POWER
T
S
CARDIOVERSION
PROGRAMMING
MAIN
MENU
DEFIBRILLATION
SHOCK
DEFIBRILLATION SHOCK
X A X A
B B B
NOMINAL ACTIVE CAN OFF SVC OFF
B > AX B>X B>A
SHOCKING VECTORS
PROGRAMMING
KNOWLEDGE CHECK
QUESTION 5 OF 8
FOR INFORMATION ON
ATP BEFORE/DURING
CHARGING CLICK
HERE
CONFIRMING THERAPY DELIVERY
ATP DURING CHARGING
Patient’s rhythm is monitored while the ICD is charging.
During this confirmation phase, the ICD will compare the current arrhythmia cycle
length to the calculated confirmation interval. This calculated confirmation interval
is based on the rate of the detected arrhythmia.
ATP BEFORE DURING CHARGING
PROGRAMMING
CHARGESAVER™ AND SWITCHBACK™
DETAILED OPERATION
Switches between ATP During Charging and ATP Before Charging based
on ATP success.
ChargeSaver™ SwitchBack™
Switches to ATP BC Switches to ATP DC
after one* ATP DC after two ATP BC
success failures
FOR INFORMATION ON
CHARGESAVER/
SWITCHBACK CLICK
HERE
KNOWLEDGE CHECKPOINT
QUESTION 7 OF 8
What type of episode was detected and what therapy was delivered?
A. VF, Defibrillation
B. VT, Cardioversion
C. FVT, ATP
D. VF, ATP
KNOWLEDGE CHECK
QUESTION 8 OF 8
Is ATP During
Charging™
successful at
terminating the
arrhythmia in this
rhythm strip?
A. Yes
B. No
MAIN
MENU
CONFIRMATION
CONFIRMING THERAPY DELIVERY
CONCEPT
Before the ICD delivers the first defibrillation shock for a VF episode, it
monitors the cardiac rhythm to confirm VF remains present.
If difference Confirmation
>50ms, Interval =
rhythm is VF Detection
polymorphic Interval + 60ms
*Confirmation Interval must
be at least equal to VFDI
• Confirmation uses the intervals following the delivery of ATP During Charging
to apply the confirmation process.
• VF Rx1 can abort more than once per episode
CONFIRMING THERAPY DELIVERY
CONFIRMING VT OR FVT AFTER DETECTION
VT detected & Charging starts VT spontaneously terminates Device aborts therapy and stops
and normal sinus rhythm charging
Begin to confirm tachyarrhythmia resumes
SUMMARY
SUMMARY
1Sweeney MO, Hellkamp AS, Ellenbogen KA, et al. Adverse effect of ventricular pacing on
heart failure and atrial fibrillation among patients with normal baseline QRS duration in a
clinical trial of pacemaker therapy for sinus node dsyfunction. Circulation.
2003:107(23):2932-2937.
2 Wathen MS, Sweeney MO, DeGroot PJ, et al. Shock Reduction using antitachycardia
pacing for spontaneous rapid ventricular tachycardia in patients with coronary artery disease.
Circulation. 2001;104:796-801.
3 Wathen MS, DeGroot PJ, Sweeney MO, et al. Prospective randomized multicenter trial of
empirical antitachycardia pacing versus shocks for spontaneous rapid ventricular tachycardia
in patients with implantable cardioverter-defibrillators. Pacing Fast Ventricular Tachycardia
Reduces Shock Therapies (PainFREE Rx II) trial results. Circulation. 2004;110:2591-2596.
4Medtronic Evera MRI™ system reference guide. www.medtronic.com/manuals
CONCEPTS OF ICD
TECHNOLOGY
SVT
DISCRIMINATION
ALGORITHMS
JULY 2017
DISCLOSURES
This presentation is provided for general educational purposes only and should not
be considered the exclusive source for this type of information. This training does
not replace or supersede approved labeling. The content will be shared with
physicians and allied health professionals who seek a deeper understanding of the
operation and use of Medtronic products and therapies with the intent of enhancing
their knowledge of features and operations described in the clinician manuals.
Patient information (names, serial numbers, date, etc.) has been changed or
removed to protect the privacy of the patients used in this presentation.
Important Reminder: This information is intended only for users in markets where
Medtronic products and therapies are approved or available for. Content on
specific Medtronic products and therapies is not intended for users in markets that
do not have authorization for use.
OBJECTIVES
Onset of the
arrhythmia
Relationship between
P- and R-waves
Wavelet Onset
PR Logic™ Stability
* Wavelet was introduced in dual and triple chamber Protecta ICD models in 2011
WAVELET
RHYTHM MORPHOLOGY
1
EGM: Atip
ECG to Aring
EGM: Can
to RV Coil
2
ECG
EGM: Atip
to Aring
EGM: Can
to RV Coil
WAVELET FEATURE
OPERATION
Compares how well the current EGM morphologies compare to the NSR
(template) and assigns a “match” or “no match”
If ICD decides there are enough “matches”, therapy is withheld and the rhythm is
monitored
Signal too
Signal too
large
small
(clipped)
FIX FIX
PR LOGIC
PR LOGIC
IDENTIFIES AND CLASSIFIES THE FOLLOWING RHYTHMS:
PR LOGIC
HOW IT WORKS
PR LOGIC
ALGORITHM
NO NO NO
YE
YE
YE
S
S
S
Gradual
entrance to
arrhythmic
zone
Abrupt
entrance into
the
arrhythmic
zone
ONSET
EGM
Applies only in VT zone
ONSET Nominally programmed Off
PROGRAMMING Requires an onset percentage
to be programmed
ONSET
CONSIDERATIONS Atrial Paced, Ventricular Sensed
VT with dissociated A and V
VT
Apace-Vsense
*Onset prevents the VT counter from incrementing, and therefore detection. As a result,
discriminators such as PR Logic and Wavelet that are applied once the NID is met are never
applied.
STABILITY
STABILITY What is the rhythm?
INTERVAL PLOT & EGM What is the device’s
response?
During atrial fibrillation, atrial events can be
STABILITY irregularly conducted to the ventricle
PROGRAMMING VT counter reset when V. cycle length varies by
more than programmed stability interval
STABILITY Stability inappropriately withholding VT detection
CONSIDERATIONS
CLINICAL EVIDENCE
HISTORICAL CLINICAL EVIDENCE
SmartShock™ 2.0 Technology is defined as: Wavelet, PR Logic*, SVT Discriminators in the VF zone, Confirmation+, T-Wave Discrimination, RV
Lead Integrity Alert, RV Lead Noise Discrimination and Alert, and a nominal NID of 30 out of 40.
*PR Logic does not apply to VR devices
KNOWLEDGE
CHECKS
KNOWLEDGE CHECKPOINT
QUESTION 1 OF 6
Match the description to each SVT discriminator
Uses differences in morphologies
between rhythms of ventricular origin
Stability and those of supraventricular origin.
Select the rhythm that is best represented in the following interval plot.
A. Sinus tachycardia
B. VT
C. AVNRT
D. Atrial Fibrillation
KNOWLEDGE CHECK
QUESTION 3 OF 6
A. Wavelet
B. Stability
C. Onset
D. PR Logic
KNOWLEDGE CHECKPOINT
QUESTION 4 OF 6
True or False: A rhythm with the displayed QRS snapshots will cause
therapy to be withheld. (Match threshold = 70%)
A. True
B. False
KNOWLEDGE CHECK
QUESTION 5 OF 6
Review the following
episode plot diagram and
EGM. What algorithm is
withholding detection of
VT?
A. Onset
B. Stability
C. Wavelet
D. PR Logic
KNOWLEDGE CHECK
QUESTION 6 OF 6
Is this appropriate detection
of VT?
A. Yes
B. No
SUMMARY
SUMMARY
ICDs use SVT discrimination algorithms to differentiate
supraventricular tachyarrhythmias from ventricular
arrhythmias.
If you are located in the United States, please refer to the brief statement(s) below to
review applicable indications, safety and warning information. See the device manual for
detailed information regarding the implant procedure, indications, contraindications,
warnings, precautions, and potential complications/adverse events. For further information,
please call Medtronic at 1.763.514.4000 and/or consult the Medtronic website
at www.medtronic.com.
If you are located outside the United States, see the device manual for detailed
information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential adverse events. For further information, contact your local
Medtronic representative and/or consult the Medtronic website at www.medtronic.com.
Consult instructions for use at this website. Manuals can be viewed using a current version of
any major Internet browser. For best results, use Adobe Acrobat Reader® with the browser.
BRIEF STATEMENT (USA): ICDS
Indications
Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation
for automated treatment of life-threatening ventricular arrhythmias. Some ICDs are also indicated for use in patients with
atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias.
Notes on some features in ICDs: The RV Lead Integrity Alert (LIA) feature is intended primarily for patients who have a
Medtronic ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930), based on performance data.
The RV LIA feature may not perform as well with a St. Jude Riata/Durata lead or a Boston Scientific Endotak lead as it does
when used with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures
and conditions that may or may not be detected early by the RV LIA feature. The clinical value of the OptiVol fluid monitoring
diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart
failure. Additional notes for DR ICDs: The use of the device has not been demonstrated to decrease the morbidity related to
atrial tachyarrhythmias. The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device
classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to
be 16.8%, in the VT/AT patient population studied. The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst
therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified
atrial fibrillation (AF) was found to be 18.2% in the AF-only patient population studied.
Contraindications
ICDs are contraindicated in patients experiencing tachyarrhythmias with transient or reversible causes including, but not
limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance,
hypoxia, or sepsis; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT)
or ventricular fibrillation (VF), and patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT
or VF.
BRIEF STATEMENT (USA): ICDS
Warnings/Precautions
Changes in a patient's disease and/or medications may alter the efficacy of the device's programmed parameters. Patients
should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing
and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset or device damage. Do not place
transthoracic defibrillation paddles directly over the device.
Potential complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve
stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and surgical complications such as
hematoma, infection, inflammation, and thrombosis. An additional complication for ICDs is the acceleration of ventricular
tachycardia.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518
and/or consult Medtronic's website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
BRIEF STATEMENTS (USA): CRT DEFIBRILLATORS (ICDS)
Indications
Cardiac Resynchronization Therapy (CRT) ICDs are indicated for ventricular antitachycardia pacing and ventricular
defibrillation for automated treatment of life-threatening ventricular arrhythmias and for providing cardiac resynchronization
therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following
classifications: New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular ejection
fraction < 35% and a prolonged QRS duration. Left bundle branch block (LBBB) with a QRS duration > 130 ms, left
ventricular ejection fraction < 30%, and NYHA Functional Class II. NYHA Functional Class I, II, or III and who have left
ventricular ejection fraction ≤ 50% and atrioventricular block (AV block) that are expected to require a high percentage of
ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure
medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant. Some CRT ICDs
are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing
atrial tachyarrhythmias. The RV Lead Integrity Alert (LIA) feature is intended primarily for patients who have a Medtronic
ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930, based on performance data. The RV
LIA feature may not perform as well with a St. Jude Riata/Durata lead or a Boston Scientific Endotak lead as it does when
used with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures and
conditions that may or may not be detected early by the RV LIA feature.
Contraindications
CRT ICDs are contraindicated in patients experiencing tachyarrhythmias with transient or reversible causes including, but
not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance,
hypoxia, or sepsis; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT)
or ventricular fibrillation (VF), and patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT
or VF.
BRIEF STATEMENTS (USA): CRT DEFIBRILLATORS (ICDS)
Warnings/Precautions
Changes in a patient’s disease and/or medications may alter the efficacy of the device’s programmed parameters. Patients
should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing
and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset or device damage. Do not place
transthoracic defibrillation paddles directly over the device.
Additionally, for CRT ICDs and CRT IPGs, certain programming and device operations may not provide cardiac
resynchronization. Also for CRT IPGs, Elective Replacement Indicator (ERI) results in the device switching to VVI pacing at
65 ppm. In this mode, patients may experience loss of cardiac resynchronization therapy and / or loss of AV synchrony. For
this reason, the device should be replaced prior to ERI being set. Use of the device should not change the application of
established anticoagulation protocols.
Potential Complications
Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve
stimulation, oversensing, failure to detect and/or terminate arrhythmia episodes, and surgical complications such as
hematoma, infection, inflammation, and thrombosis. An additional complication for CRT ICDs is the acceleration of
ventricular tachycardia.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings,
precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518
and/or consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
BRIEF STATEMENT (USA): MEDTRONIC CARELINK 2090
PROGRAMMER
The Medtronic CareLink programmer system is comprised of prescription devices indicated for use in the interrogation and
programming of implantable medical devices. Prior to use, refer to the Programmer Reference Guide as well as the
appropriate programmer software and implantable device technical manuals for more information related to specific
implantable device models. Programming should be attempted only by appropriately trained personnel after careful study
of the technical manual for the implantable device and after careful determination of appropriate parameter values based
on the patient's condition and pacing system used. The Medtronic CareLink programmer must be used only for
programming implantable devices manufactured by Medtronic or Vitatron.
See the device manuals for detailed information regarding the instructions for use, indications, contraindications, warnings,
precautions, and potential adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or
consult Medtronic’s website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Contraindications
There are no known contraindications.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
Updated Nov 16 2015
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2017