6943
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Device Survival Probability
6943_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.5 | 97.7 | 96.5 | 95.4 | 93.3 | 91.4 | 90.1 | 89.2 | 86.2 | 85.9 | 82.5 | 80.5 | 79.9 | 77.1 | |||||||
| # | 1161 | 981 | 855 | 702 | 584 | 477 | 394 | 324 | 270 | 214 | 182 | 143 | 95 | 57 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1339 |
|---|---|
| Cumulative Months of Follow-Up | 85794 |
| Number of Leads Active in Study | 70 |
113
Qualifying Complications
| Conductor Fracture | 32 |
|---|---|
| Failure to Capture | 12 |
| Failure to Sense | 7 |
| Impedance Out of Range | 9 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 2 |
| Oversensing | 44 |
| Other | 2 |
| Unspecified Clinical Failure | 3 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 1 |
| Failure to Sense | 1 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 1997-10-06 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 20581 |
| Estimated Active USA Implants | 4633 |
| US Market Release | 1997-10-06 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 37257 |
USA Returned Product Analysis
| Conductor Fracture | 89 |
|---|---|
| Insulation Breach | 33 |
| Crimp/Weld/Bond | 1 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 246 |
|---|---|
| Insulation Breach | 91 |
| Crimp/Weld/Bond | 1 |
| Other | 22 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Active Screw In |
| Lead Function | Pacing/Sensing and Defibrillation |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | True Bipolar/One Coil |
| Serial Number Prefix | TCE |
|---|---|
| Lead Body Diameter | 7.8 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | DF-1 |
| Steroid | Yes |
Data as of July 31, 2017