Steroid-Eluting Pace/Sense and Defibrillation Silicon Lead with
Lubricious Coating Extendable/Retractable Helix
0184/0185/0186/0187 0180/0181
MRI
0184/0185/0186/0187 ENDOTAK
ENDOTAK
ICD Y
0184/0185/0186/0187 ENDOTAK
ENDOTAK
ICD Y
MRI (MR
Conditional System Information)
MRI
MRI
MRI
4
MRI
0184/0185/0186/0187 ENDOTAK
D
0184/0185/0186/0187 ENDOTAK
D
3. www.bostonscientific-elabeling.com
American College of
MR Practices5 Zone III
MRI
Zone III IV
Roentgenology 188:1447-74, 2007.
Guide)
RELIANCE SG
RELIANCE SG
MRI
MRI
MRI
Precautions.................................................................
4 Potential Adverse Events...................... 5
Warranty......................................................................
5
LEAD
FEATURES.........................................................................6
Handling the Lead.................................... 13
IMPLANTATION.........................................................................................14
Inserting the Stylet................................... 14 Handling
the Fixation Helix............... 14 Inserting the
Lead.............................................. 15 Positioning
the Lead................................... 18 Lead
Fixation..................................................... 19
Checking for Lead Stability.......... 21 Repositioning the
Lead........................... 21
Evaluating Lead Position............................ 21 Minimizing
Pacemaker Interaction........................................ 22
Taking Baseline Measurements........................... 22
Electrical Performance.......................................... 23
Evaluating with the Device..................... 23 ECD Evaluating
with the ECD....................... 24
Conversion Testing........................................ 24
Securing the Lead............................................. 26
Percutaneous Implant Technique.............. 26 Venous Cut-Down
Technique........................... 26
(Abdominal Implants)Model 0187................. 28 Tunneling the
Lead to the Abdominal Pocket....................... 28 Connection
to the Device.................................. 29
POST-IMPLANT EVALUATION......................................29
Explantation......................................................................
30
SPECIFICATIONSNominal...............................................................31
ENDOTAK RELIANCE G/SG DEVICE DESCRIPTION
1
VENTAK® ECDENDOTAK SQ ARRAY ENDOTAK SQ ARRAYICD Y ICD Y
Indications for Use ENDOTAK RELIANCE GModel 0184/0185/0186/0187
ENDOTAK RELIANCE SG Model 0180/0181 ICD/CRT-D
Contraindications
1. GOREW. L. Gore and Associates 2. DF-1 ISO 11318:1993 3. IS-1 ISO
5841-3:1992
ENDOTAK RELIANCE G/SG DEVICE DESCRIPTION
2
Warnings
ICD/CRT-D Lead Compatibility ENDOTAK ICD/ CRT-D
MRI MRI Exposure
(Diathermy Exposure)
Air embolism Allergic reaction Bleeding Cardiac
perforation/tamponade Chronic nerve damage Death Elevated
thresholds Erosion/extrusion Excessive fibrotic tissue growth
Formation of hematomas or cysts Inappropriate therapy/shocks
Incomplete connection with pulse generator Infection Keloid
formation Lead abrasion Lead displacement/dislodgment Lead
fracture, insulation break
Lead tip deformation and/or breakage Local tissue reaction Low
amplitude VF signals Myocardial injury Myocardial irritabillity
Oversensing/ undersensing Pheumothorax Post-shock rhythm
disturbances Random component failures Shunting current or
insulating myocardium during defibrillation with internal or
external paddles Threshold elevation Thrombosis/thromboemboli
Venous occlusion Venous perforation
ENDOTAK RELIANCE G/SG LEAD FEATURES
6
LEAD FEATURES ENDOTAK RELIANCE G ENDOTAK RELIANCE SG :
1.0 mg
Cathode
X X X
Anode Cathode AnodeENDOTAK RELIANCE G Anode Cathode ENDOTAK
RELIANCE
GORE™ ePTFE ePTFE
ENDOTAK RELIANCE G 2 ENDOTAK RELIANCE SG 1 PTFE
ENDOTAK RELIANCE
ENDOTAK RELIANCE G/SG LEAD FEATURES
7
1. 9StCp
2. StCp Ax
3. V
4. Magney JE, et al. Anatomical mechanisms explaining damage to
pacemaker leads, defibrillator leads, and failure of central venous
catheters adjacent to the sternoclavicular joint. PACE.
1993;16:445-457.
5. Magney JE, et al. A new approach to percutaneous subclavian
venipuncture to avoid lead fracture or central venous catheter
occlusion. PACE. 1993;16:2133-2141.
ENDOTAK RELIANCE G/SG IMPLANTATION
17
5.
9.
18
10.
19
ICD/CRT-D
ICD
Lead Fixation ENDOTAK RELIANCE G ENDOTAK RELIANCE SG
1. 13
2.
12. ENDOTAK RELIANCE SG
20
SPECIFICATIONS31 X
3.
14.
21
Checking for Lead Stability 8 10 cm X
Evaluating Lead Position ECD X
ENDOTAK RELIANCE G/SG IMPLANTATION
22
ICD Tachy Mode Monitor + Therapy
EP
Taking Baseline Measurements PSA
PSA 2
6. Epstein AE, et al. Combined automatic implantable
cardioverter-defibrillator and pacemaker systems: implantation
techniques and follow-up. JACC. 1989;13:121-131.
7. Calkins H, et al. Clinical interactions between pacemakers and
automatic implantable cardioverter-defibrillators. JACC.
1990;16:666-673.
R
23
R
Electrical Performance ECD
ECD
ECD ECDOFF ECD ECDECD
Evaluating with the Device Connection to the Device29
2. a
b. c.
ENDOTAK RELIANCE G/SG IMPLANTATION
24
ECD Evaluating with the ECD ECD
PRM ICD/CRT-D