Medtronic MICSIMPLANT Users Manual
ECO Market Release DBLxxxxxxxxxxx
PRELIMINARY DRAFT
Printinginstructions:doc#
xxxxxx;referto’Implantmanuals’rowintheapplicabletable.
MARQUIS II DRXXXX
DualChamberImplantableCardioverterDefibrillator
Implant Manual
Caution: Federal law (USA) restricts this
device to sale by or on the order of a
physician or properly licensed practitioner.
-- DRAFT
198483001 C Medtronic Confidential Composed: 2002-02-14 11:48
MedtronCRM
B,C xxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxxx
Printing instructions: doc#
xxxxxx; refer to ’Implant manuals’ row in the applicable table.
The following are trademarks of Medtronic.
Active Can, CapSure, Cardiac Compass, Flashback, GEM, GEM DR, Marker Channel,
Marquis
II, Medtronic, PR Logic, Patient Alert, Quick Look, Sigma
198483001 C Medtronic Confidential Composed:
MedtronCRM B
xxxx-xx-xx 11:48
,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxx
Printing instructions: doc#xxxxxxx; refer to ’Implant manuals’ row in the applicable table.
Table of Contents
1 Description 3
2 Indications and usage 3
3 Contraindications 3
4 Warnings and precautions 3
4.1 Storage and handling 4
4.2 Resterilization 4
4.3 Device operation 4
4.4 Lead evaluation and lead connection 5
4.5 Follow-up testing 5
4.6 Explant and disposal 6
4.7 Medical therapy hazards 6
4.8 Home and occupational environments 7
5 Adverse events 8
5.1 Observed adverse events 8
5.2 Potential adverse events 10
6 Clinical studies 11
6.1 Acute study 11
6.2 Implant study 11
7 Patient selection and treatment 15
7.1 Individualization of treatment 15
7.2 Specific patient populations 15
8 Patient counseling information 16
9 Conformance to standards 16
10 How supplied 16
11 Clinician use information 16
11.1 Physician training 16
11.2 Directions for use 16
11.3 Maintaining device effectiveness 17
12 Patient information 17
13 Implant procedure 17
13.1 Pre-operative programming 18
13.2 Testing lead operation 18
13.3 Connecting leads to the implanted device 19
13.4 Defibrillation threshold testing 20
13.5 Placing the device 21
13.6 Programming 21
13.7 Replacing an old ICD 21
14 Feature summary 22
14.1 Tachyarrhythmia operations 22
14.2 Pacing operations 22
1
198483001 C Medtronic Confidential Composed: 2xxxx-xx-xx 11:48
MedtronCRM B,Cxxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxxx
Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
14.3 Monitoring operations 23
15 Product specifications 23
15.1 Physical specifications (nominal) 23
15.2 Replacement indicators 23
15.3 Projected longevity 24
15.4 Magnet behavior 26
15.5 Functional parameters 26
2
198483001 C Medtronic Confidential Composed:
MedtronCRM B
xxxx-xx-xx 11:48
,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxxx
Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
1 Description
The Mode lXXXX Marquis II DR Implantable Cardioverter Defibrillator (ICD) System is a multiprogrammable,
implantable cardioverterdefibrillator thatmonitorsand regulates a patient’s heart rate by providing ventricular
arrhythmia therapy, and single or dual chamberrate responsive bradycardia pacing.
The Model XXXX
defibrillation leads, constitutes the implantable portion of the ICD system. The lead systems for the
Marquis II DR system are implanted using standard transvenous placement techniques.
The Model 9790C programmer, Model 9966 software, Model 9466 patient magnet, Model 9322 SmartMagnet
and Model 9767 (or Model 9767L) programminghead constitute one external portion of the ICD system.
The Model 2090 programmer is compatible. Programmers from other manufacturers are not compatible.
Contents of sterile package – Thesterile package contains one implantable cardioverter defibrillator, one
torque wrench, and one DF–1 pin plug.
About this manual – This document is intended primarily as an implant manual. Regular patient
follow-up sessions should be scheduled after implant. Follow-up procedures such as monitoring battery
measurements and confirming therapy parameters are described in the manual included with the software
supporting the Model XXXX Marquis II DR ICD. (To obtain additional copies of this manual, contact your
Medtronic representative.)
Marquis II DR ICD, along with commercially available pace/sense leads and cardioversion/
2 Indications and usage
The implantable cardioverter defibrillator is intended to provideventricular antitachycardia pacing and
ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias.
3 Contraindications
The Marquis II DR system is contraindicated for
patients whose tachyarrhythmias may have transient or reversible causes, such as: acute myocardial
•
infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia, or sepsis.
patients with incessant VT or VF
•
patients who have a unipolar pacemaker
•
patients whose primary disorder is bradyarrhythmiasor atrial arrhythmias
•
4 Warnings and precautions
Avoiding shock during handling – Programtachyarrhythmia detection Off during surgical implant and
explant or post-mortem procedures because the ICD can deliver a serious shock if you touch the defibrillation
terminals while the ICD is charged.
Electrical isolation during implantation – Do not permit the patient to contact grounded equipment,
which could produce hazardous leakage current during implantation. Resulting arrhythmia induction could
result in the patient’s death.
Lead system – Do not use another manufacturer’s lead system without demonstrated compatibility, as
undersensing of cardiacactivity and failure to deliver necessary therapy could result.
Resuscitation availability – Do not perform ICD testing unless an external defibrillator and medical
personnel skilled in cardiopulmonary resuscitation (CPR) are readilyavailable.
3
198483001 C Medtronic Confidential Composed: 2xxxx-xx-xx 11:48
MedtronCRM B,C xxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxxxx
Printing instructions: doc#xxxx refer to ’Implant manuals’ row inthe applicable table.
4.1 Storage and handling
Checking and opening the package – Before opening the sterile package tray, visually check for any signs
of damage that might invalidate the sterility of itscontents. Return damaged packages to the manufacturer.
For instructions on opening the sterile package, see the diagram inside the lid of the shelf box.
Device storage – Store the devicein a clean area, away from magnets, kits containing magnets, and
sources of electromagnetic interference to avoid device damage.
Dropped device – Do not implant the device if ithas been dropped on a hard surface from a height of 30 cm
(12 in) or more after removal from its packaging.
Equilibration – Allow the device to reach room temperature before programming or implanting, because
rapid temperature changes could affect initial device function.
Temperature limits – Store and transport the package between -18
“Use By” Date – Do not implant the device after the “Use By” date because the battery longevity could
be reduced.
C (0F) and +55C (+131F).
4.2 Resterilization
Medtronic has sterilizedthe device package contents with ethylene oxide prior to shipment. Resterilization is
necessary only if the seal onthe sterile package is broken. (Resterilization does not affectthe "Use By"
date.) If necessary, resterilize with ethylene oxide using a validatedsterilization process, observing the
following precautions:
Do not resterilize the device using an autoclave, gamma radiation, organic cleaning agents(such as
•
alcohol, acetone, etc.), or ultrasonic cleaners.
Do not resterilize the device more than twice.
•
Do not exceed 55
•
C (131F) or 103 kPa (15 psi) when sterilizing.
4.3 Device operation
Accessories – The device may be used only with accessories, parts subject to wear and disposable items,
of which the completely safe use on safety and technical groundshas been demonstrated by a testing
agency approved for the testing of the device.
Battery depletion – Battery depletion will eventually cause the device to cease functioning and should be
carefully monitored. Cardioversion and defibrillation are high energy therapies and may quickly deplete
the battery and shorten the devicelongevity. An excessive number of charging cycles will also shorten
the longevity.
Charge Circuit Timeout or Charge CircuitInactive – Replace the device immediately if the programmer
displays a Charge Circuit Timeout or Charge Circuit Inactivemessage.
Concurrent pacemaker use – If a pacemaker is used concurrently with the ICD, verify that the ICD will not
sense the pacemaker output pulses. Program the pacemaker so that pacing pulses are delivered at intervals
longer than the ICD tachyarrhythmia detection intervals.
End of Life (EOL) indicator – Replace the device immediately if the programmer displays an End of
Life (EOL) symbol.
Higher energy on the output capacitor – A higher than programmed energy canbe delivered to the
patient when the device has been previously charged to a higher energy and the energy is still present on
the output capacitors.
Lead compatibility – Do not use another manufacturer’s lead system without demonstrated compatibility as
undersensing of cardiacactivity and failure to deliver necessary therapy could result.
Medical treatment influencing device operation – The electrophysiological characteristics of a patient’s
heart can alter over time and the programmed therapies may become ineffective and even dangerous to the
patient. Thisis especially to be considered when the patient’s drug treatment has changed.
4
198483001 C Medtronic Confidential Composed:xxxx-xx-xx 11:48
MedtronCRM B,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxx
Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row in the applicable table.
Pacemaker dependent patients – Always program Ventricular Safety Pacing (VSP) On for pacemaker
dependent patients.
Programmers – Use only Medtronic programmers, application software, and accessories tocommunicate
with the device.
Use of a magnet – Positioning a magnet over the device suspends detection and treatment but does not
alter bradycardia therapy. The programming head contains a magnet that can suspend detection, but if
telemetry between the device and programmer is established, detection is notsuspended.
4.4 Lead evaluation and lead connection
Use only ethylene oxide for lead resterilization. Do not resterilize more than one time.
•
Do not tie a ligature directly to the lead body, tie it too tightly, or otherwise create excessive strain at
•
the insertion site as this can damage the lead.
Do not immerse leads in mineral oil, silicone oil, or any other liquid.
•
Do not grip the lead with surgical instruments.
•
Do not use excessive force or surgical instrumentsto insert a styletinto a lead.
•
Use the same polarity evaluated during testing when connecting the leads to the ICD to ensure
•
defibrillation effectiveness.
Do not fold, alter, or remove any portion of the patch because doing so could compromise electrode
•
function or longevity.
Do not use ventricular transvenousleads in patients with tricuspid valve disease or a mechanical
•
prosthetic tricuspid valve. Use withcaution in patients with a bioprosthetic valve.
Use the correct suture sleeve (when needed) for each lead to immobilize the lead and protect it against
•
damage from ligatures.
Ensure that the defibrillation lead impedance is greaterthan 20
•
damage the ICD.
Do not kink the leads. Kinking leads can cause additional stress on the leads, possibly resulting
•
in lead fracture.
Do not suture directly over the lead body as this may cause structural damage. Use the lead anchoring
•
sleeve to secure the lead lateral to the venous entry site.
Lead or Active Can electrodes in electricalcontact during a high voltage therapy could cause current to
•
bypass the heart, possibly damaging the ICD and leads. While the ICD is connected to the leads, make
sure that no therapeutic electrodes, stylets, or guidewires are touching or connected by an accessory
low impedance conductive pathway. Move objects made from conductive materials (e.g., an implanted
guidewire) well away from all electrodes before a high voltage shock is delivered.
Make sure tocap any pacing lead that is abandoned rather than removed to ensure that the lead does
•
not become a pathway for currents to or from the heart.
Make sure to plug any unused lead port in the device to protect the ICD.
•
Refer to the lead technical manuals for specific instructions and precautions about lead handling.
•
. An impedance below 20could
4.5 Follow-up testing
Ensure that an external defibrillator and medical personnel skilled in cardiopulmonary resuscitation
•
(CPR) are present during post-implant ICD testing should the patient require external rescue.
Be aware that changes in the patient’s condition, drug regimen, and other factors may change the
•
defibrillation threshold (DFT), which may result in nonconversion of the arrhythmia post-operatively.
Successful conversion of ventricular fibrillation or ventricular tachycardia during testing is no assurance
that conversion will occur post-operatively.
5
198483001 C Medtronic Confidential Composed:xxxx-xx-xx 11:48
MedtronCRM B,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxxx
Printing instructions: doc#xxxxxx; refer to ’Implant manuals’ row inthe applicable table.
4.6 Explant and disposal
Interrogate the ICD, program VF and VT Detection Off, and disable ICD functions prior to explanting,
•
cleaning, or shipping the ICD to prevent unwanted shocks.
Explant the ICD postmortem. In some countries, explanting battery-operated implantable devices is
•
mandatory because of environmentalconcerns; please checkyour local regulations. In addition, if
subjected to incineration or cremation temperatures, the device could explode.
Medtronic implantable devices are intended forsingle use only. Do not resterilize and re-implant
•
explanted devices.
Please return explanted devices to Medtronic foranalysis and disposal. See the back cover for mailing
•
addresses.
4.7 Medical therapy hazards
Diathermy – People with metal implants such as pacemakers, implantable cardioverter defibrillators (ICDs),
and accompanying leads should not receivediathermy treatment. The interaction between the implant and
diathermy can cause tissue damage, fibrillation, or damage to the device components, which could result in
serious injury, loss of therapy, and/or the needto reprogram or replace the device.
Electrosurgical cautery – Electrosurgicalcautery could induce ventricular arrhythmias and/or fibrillation,
or may cause implanteddevice malfunction or damage. If electrocautery cannot be avoided, observe the
following precautions to minimize complications:
Have temporary pacing and defibrillation equipment available.
•
Program the implanted device to the DOO mode.
•
Suspend tachyarrhythmiadetection using a magnet, or turn detection Off using the programmer.
•
Avoid direct contact with the implanted device or leads. If unipolar cautery is used, position the ground
•
plate so thatthe current pathway does not pass through or near the implanted device system (minimum
of 15 cm [6 in]).
Use short, intermittent, and irregular bursts at the lowest feasible energy levels.
•
Use a bipolar electrocautery system, where possible.
•
External defibrillation – External defibrillation may damage the implanted device or may result in temporary
and/or permanent myocardial damage at the electrode tissue interface as well as temporary or permanent
elevated pacing thresholds. Attempt to minimize the voltage potential across the deviceand leads by
following these precautions:
Use the lowest clinically appropriate energy output.
•
Position defibrillation patches or paddlesas far from the device as possible (minimum of 15 cm [6 in]),
•
and perpendicular to the implanted device-lead system.
If an external defibrillation was delivered within 15 cm (6 in) of the device, contact your Medtronic
representative.
High-energy radiation – Diagnostic X-ray and fluoroscopic radiation should not affect the device; however,
high-energy radiation sources such as cobalt 60 or gamma radiation should not be directed at the device. If a
patient requires radiation therapy in the vicinity of the device, place lead shielding over the implant site as a
precaution against radiation damage.
Lithotripsy – Lithotripsy may permanently damage the implanted deviceif it is at the focal point of the
lithotripsy beam. If lithotripsy must be used, temporarily turn off ICD therapies during the lithotripsy procedure
and keep the focal point of the lithotripsy beam at least 2.5 to 5 cm (1 to 2 in) from the implanted device.
Magnetic resonance imaging (MRI) –Magnetic resonance imaging (MRI) should not be used on patients
who have an implanted cardiac device because of the potential damage to the implanted device.
6
198483001 C Medtronic Confidential Composed:xxxx-xx-xx 11:48
MedtronCRM B,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxx
Printing instructions: doc#xxxxxxx refer to ’Implant manuals’ row in the applicable table.
Radio frequency (RF) ablation – Radio frequency ablation procedure in a patient with an implanted cardiac
device could cause implanted device malfunction or damage. To minimize the risks from radio frequency
ablation,
Have temporary pacing and defibrillation equipment available.
•
Program the implanted device to the DOO mode.
•
Suspend tachyarrhythmiadetection using a magnet, or turn detection Off using the programmer.
•
Avoid direct contact between the ablation catheter and the implanted lead ordevice.
•
Position the groundplate so that the current pathway does not pass through or near the implanted
•
device system (minimum of 15 cm [6 in]).
Therapeutic ultrasound – Exposure of the device to therapeutic ultrasound is notrecommended as it may
permanently damage the device. Damage to the devicemay affect therapy.
4.8 Home and occupational environments
Cellular phones – Marquis
interacting with device operation. To further minimize the possibility of interaction, observe the following
cautions:
Maintain a minimum separation of 15 cm (6 in) between the device and the hand-held telephone handset.
•
Maintain a minimum separation of 30cm (12 in) between the device and any antenna transmitting
•
above 3 watts.
Hold the handset to the ear furthest from the implanted device.
•
Do not carry the handset within 15 cm (6 in) of the implanted device (even if the handset is not on).
•
The ICD has been tested using the ANSI/AAMI PC-69standard to ensure compatibility with hand-held
wireless and PCS phones andother similar power hand-held transmitters. These transmission technologies
represent the majority of the cellular telephones in use worldwide. The circuitry of this device, when operating
under nominal conditions, has been designed to eliminate any significant effects from the cellular telephones.
Commercial electrical equipment – Commercial electrical equipment such as arc welders,induction
furnaces, or resistance welders could generate enough EMIto interfere with device operation if approached
too closely.
Communication equipment – Communication equipment such as microwave transmitters, line power
amplifiers, or high-power amateur transmitters could generate enough EMI to interfere with device operation
if approached too closely.
Electric or magnetic interference (EMI) – Patients should be directed to avoid devices that generate strong
electric or magnetic interference (EMI). EMI could cause malfunction or damage resulting inprevention of
proper programming, or confirmation, non-detection or delivery of unneeded therapy. Moving away from the
interference source, or turning it off, usually allows the device to return to its normal modeof operation.
Electronic article surveillance (EAS) – EAS equipment such as retail theft prevention systems may interact
with the implanted device. Patients should be advised to walkdirectly through, and not to remain near an
EAS system longer than is necessary.
High voltage lines – High voltage power transmission lines could generate enough EMI to interfere with
device operation if approached too closely.
Home appliances – Home appliances which are in good workingorder and properly grounded do not usually
produce enough EMI to interfere with device operation. Thereare reports of temporary disturbances caused
by electric hand tools or electric razors used directly over the implant site.
Static magnetic fields – Patients should avoid equipment or situations where they would be exposed to
static magnetic fields (greater than 10 gauss or 1 millitesla) since it couldsuspend detection. Examples of
magnetic sources that could interfere with normal device operation include: stereo speakers, bingo wand,
extractor wand, magnetic badges,or magnetic therapy products.
II DR ICDs contain a filter that prevents most cellular phone transmissions from
7
198483001 C Medtronic Confidential Composed:xxxx-xx-xx 11:48
MedtronCRM B,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxx
Printing instructions: doc#xxxx; refer to ’Implant manuals’ row inthe applicable table.
5 Adverse events
5.1 Observed adverse events
Clinical studies were not performed on the Marquis
and the GEM DR, clinical data generated by the GEM DR implant study was used to support the Marquis
The Clinical study of the GEM DR system (approved October 1998) included 300 ICDs implanted in 300
patients worldwide, and 297 Model 6940 CapSure Fix leads implanted in 295 patients worldwide. Total
ICD exposure was 828 device months. Individual patient exposure averaged 2.8 months (ranging from
0 to 5.3 months).
Each adverse event was reviewed by an independent clinical events committee to determine whether it
was related to the ICD system and/or the implantation procedure. There were a total of 15 deaths in the
300 patient clinical study; all were judged to be non-ICD related by the clinical events committee. Table 1
reports the causes of patient death during the clinical study in descending order of frequency. Except where
noted, all deaths were non-sudden cardiac deaths.
Table1. Patient deaths during the clinical study performed on GEM DR (approved Oct. 1998) (N=300)
Cause of Deaths (15 deaths total) # of Patients
Congestive heart failure
Cardiac and/or respiratory arrest or failure
Cardiogenic shock
Electromechanical dissociation
Ischemic cardiomyopathy
Pneumonia
a
One sudden cardiac death.
In the 300 patient clinical study one (1) device was explanted due to inappropriate VT detections.
The following adverse events were observed during the implant procedure (prior to skin closure): helix
extension failure (4 patients); cut in ventricular lead (1 patient); ST elevation (1 patient); electromechanical
dissociation (1 patient).
Table 2 and Table 3 report the adverse events attributed to theICD system and/or implant procedure, on a
per patient and per patient-year basis in descending order of frequency. The tables list complications and
observations that occurred more than once. Complications and observations that occurred only once
are listed following Table2 and following Table 3.
II DR. Because of the similarity between the Marquis II DR
When occurred (days after
5
a
5
2 12, 45
a
1
implant)
21, 50, 68, 77, 89
1, 4, 20, 21, 64
II DR.
118
1 28
1 64
8
198483001 C Medtronic Confidential Composed:xxxx-xx-xx4 11:48
MedtronCRM B,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxx
Printing instructions: doc#xxxxxx refer to ’Implant manuals’ row in the applicable table.
Table 2. Complications related to ICD system and/or implant procedure (all patients, N=300): multiple
complications. Data from GEM DR clinicalstudy (approved Oct. 1998).
a
Complications
single complications)
(total, including
Atrial lead dislodgement
Pneumothorax
Ventricular lead dislodgement
Hematoma
Respiratory failure
a
Complications are adverse events that required invasive intervention. Complications that occurred in only
one patient are listed following the table. Somepatients had more than one type of adverse event.
Single complications – Each of the following was observed once in one patient in the 300patient clinical
study: Atrial oversensing/undersensing; Failure to capture ventricle; Inappropriate ventricular detection;
Increased pulse width threshold (atrium); Infection; and Protrusion under skin.
Table 3. Observations related to ICD system and/or implant procedure (all patients, N=300): multiple
observations. Data from GEM DR clinicalstudy (approved Oct. 1998).
Observations
observations)
a
(total, including single
# of Patients
24 8.0% 31 0.45
13 4.3% 13 0.19
5
3 1.0% 3 0.04
2 0.7% 2 0.03
2 0.7% 2 0.03
Patients
Incisional pain
Inappropriate ventricular detection
Patient Alert tone triggered
Atrial oversensing/undersensing
Hematoma
Atrial fibrillation/flutter
Incessant ventricular tachyarrhythmia
Ecchymosis
CHF/CHF exacerbation
Increased DFT
Ventricular oversensing
Inadequate pace/sense measurements
(atrium)
Increased pacing threshold
Infection
% of
Patients # of Events
1.7%
# of
% of
Patients
Events
134 44.7% 189 2.74
66 22.0% 67 0.97
23 7.7% 29 0.42
11 3.7% 14 0.20
10 3.3% 11 0.16
7
2.3%
6 2.0% 6 0.09
6 2.0% 6 0.09
4 1.3% 4 0.06
3 1.0% 4 0.06
3 1.0% 3 0.04
3 1.0% 3 0.04
2 0.7% 2 0.03
2 0.7% 4 0.06
2 0.7% 2 0.03
# of
5
7
Events per
Patient-Year
0.07
Events per
Patient-Year
0.10
9
198483001 C Medtronic Confidential Composed:xxxx-xx-xx 11:48
MedtronCRM B,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxx
Printing instructions: doc#xxxxxxx; refer to ’Implant manuals’ row inthe applicable table.
Table 3. Observations related to ICD system and/or implant procedure (all patients, N=300): multiple
observations. Data from GEM DR clinical study (approved Oct. 1998). (continued)
# of
Pacemaker mediated tachycardia
Palpitations
a
Observations are adverse events that did not require invasive intervention. Observations that occurred in
only one patient are listed following the table. Some patients had more than one type of adverse event.
Single observations – Each of the following was observed once in one patient in the 300 patient clinical
study: Awareness of ventricular pacing; Bronchitis; Cardiogenic shock; Cellulitis; Cut in outer lead insulation
of 6940 lead during repositioning; Delayed wound healing; Dizziness; Failure to defibrillate/cardiovert;
Fatigue; Fever; Frequent spontaneous SVTs; Generatormigration; Inadequate pace/sense measurements
(ventricle); Insomnia; Lethargy; Multisystem failure;Near syncope; Pericardial effusion; Pneumothorax;
Pulmonary edema; Respiratory failure; Subclavianvein thrombosis; and VF therapy delivered despite
spontaneous episode termination.
Patients
% of
Patients
2 0.7% 2 0.03
2 0.7% 2 0.03
# of
Events
Events per
Patient-Year
5.2 Potential adverse events
Adverse events in alphabetical order,including those reported in Table 2 and Table 3, associated with
ICD systems include:
Acceleration of arrhythmias (caused by ICD) Air embolism
•
Bleeding
•
Chronic nerve damage
•
Erosion
•
Excessive fibrotic tissue growth
•
Extrusion
•
Fluid accumulation
•
Formation of hematomas or cysts
•
Inappropriate shocks
•
Infection
•
Keloid formation
•
Lead abrasion and discontinuity
•
Lead migration/dislodgment
•
Myocardial damage
•
Pneumothorax
•
Potential mortality due to inability to defibrillate or pace
•
Shunting current or insulating myocardium during defibrillation
•
Thromboemboli
•
Venous occlusion
•
Venous or cardiac perforation
•
Patients susceptible to frequent shocks despite antiarrhythmic medical management could develop
psychological intolerance to an ICD system that might include the following: Dependency; Depression; Fear
of premature battery depletion; Fear of shocking while conscious; Fear that shockingcapability may be lost;
Imagined shocking (phantom shock).
10
198483001 C Medtronic Confidential Composed:xxxx-xx-xx 11:48
MedtronCRM B,Cxxxx-xx-xx
ECO Market Release DBL:xxxxxxxxxxx
Printing instructions: doc#xxxxxx refer to ’Implant manuals’ row in the applicable table.
6 Clinical studies
Clinical studies were not performed on the Marquis
and the GEM DR, the GEM DR implant study was used to support the Marqui
DR system (approved October 1998) involved an acute study and an implant study.
6.1 Acute study
The study was conducted in 62 patients undergoing ICD implantation orcardiac electrophysiology (EP)
study using an external device that contained the GEM DR ICD dual andsingle chamber tachyarrhythmia
detection algorithms.
Patients studied – The patients (44 M / 18 F) had a mean age of 65.7 (range 33 – 87) years, and a mean left
ventricular ejection fraction of 36.8% (range 10 – 70%) (n=37). Arrhythmia histories included non-sustained
VT (24%), atrial fibrillation (19%), VT (18%) (non-exclusive).
Methods – The study evaluated the appropriateness of dual chamber sensing and tachyarrhythmiadetection
during induced and simulated cardiac arrhythmias. Arrhythmias(VT,VF, or SVT) were induced in 48 patients
and the episode records evaluated for relative sensitivity and incrementalspecificity.
Results – In the acute study, the GEM DR dual chamber detection algorithm (PR Logic Criteria for SVT
discrimination) demonstrated relative sensitivity (Table5) of 98.5% [95% confidence interval of 89.9 – 99.8%]
and incremental specificity (Table6) of 77.4% [63.7 – 87.0%], compared to the GEM DR single chamber
detection algorithm. No adverse interactions between sensing,pacing and detection were observed. No
adverse events occurred during the study.
6.2 Implant study
This was a non-randomized, prospective study of 300 patients implanted with the GEM DR in theU.S.,
Europe, Canada and Australia. Most (295 patients) also received a Model 6940 CapSure Fix lead. The
mean implant duration was 2.8 months (range 0 to 5.3 months), with a cumulative implant duration of
828 device months.
Patients studied – Thepatients (238 M / 62 F) had a mean age of 63.5 (range 13 to 90) years and a left
heart ventricular ejection fraction of 37.5% (10% to 82%). The primary indications for implant included
ventricular arrhythmias (47%), ventricular arrhythmias and sudden cardiac death (34%) and sudden cardiac
death (17%). Cardiovascular history included coronary artery disease and myocardial infarction (59%),
dilated cardiomyopathy (30%), congestive heart failure (26%) and hypertension (26%) (non-exclusive).
Methods – The primary objective was to demonstrate unanticipated device related effect
survival greater than 90% (lower confidence interval) at three monthspost-implant. Patients underwent
standard ICD implantation and were evaluated at one month and three months post-implant. The implant
criterion was DFT ≤ 22 J by the binary search method or 2 out of 2 successful defibrillations at ≤ 24 J.
Pacing and sensing were evaluated via ambulatory monitoring of 51 patients. Activity sensor-driven pacing
was evaluated in 20 patients who completedan exercise test. The heart ratesat rest and during exercise
were measured, and the physician reported whether or not the exertional rate
patient’s level of exercise (Table 8). Spontaneous VT/VF episodes were evaluated for therapy effectiveness
(Table 7), relative sensitivity (Table5), and incremental specificity (Table 6), using the ICD stored episode
records. Patient Alert tone identifiability was evaluated via telephone monitoring at two months post-implant.
Subthreshold (painless) lead impedance testing was performed at each visit.
II DR. Becauseof the similarity between the Marquis II DR
s II DR. Clinical study of the GEM
1
(UADRE) -free
2
was acceptable for the
1
Any “serious [incapacitating, life threatening, or fatal] unanticipated clinical event related to the ICD,”
excluding random component failure and device misuse.
2
At the end of stage 3 of the CAEP treadmill exercise challenge.
11
198483001 C Medtronic Confidential Composed:xxxx-xx-xx 11:48
MedtronCRM B,Cxxxx-xx-xx
Loading...