6966
Transvene
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | at 150 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.2 | 97.0 | 95.2 | 94.3 | 91.1 | 86.8 | 79.8 | 75.9 | 70.2 | 65.8 | 63.6 | 61.8 | 59.6 | ||||||||
| # | 1140 | 956 | 807 | 659 | 530 | 414 | 284 | 210 | 142 | 104 | 75 | 56 | 50 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1349 |
|---|---|
| Cumulative Months of Follow-Up | 75241 |
| Number of Leads Active in Study | 13 |
188
Qualifying Complications
| Conductor Fracture | 22 |
|---|---|
| Extra Cardiac Stimulation | 6 |
| Failure to Capture | 15 |
| Failure to Sense | 7 |
| Impedance Out of Range | 7 |
| Insulation (not further defined) | 14 |
| Oversensing | 112 |
| Unspecified Clinical Failure | 5 |
Advisories For This Model
- There are no advisories for this model.
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 2 |
| Failure to Sense | 1 |
| Insulation Breach | 1 |
| Lead Dislodgement | 1 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 1993-12-09 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 4687 |
| Estimated Active USA Implants | 310 |
| US Market Release | 1993-12-09 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 5098 |
USA Returned Product Analysis
| Conductor Fracture | 46 |
|---|---|
| Insulation Breach | 41 |
| Crimp/Weld/Bond | 0 |
| Other | 4 |
WW Returned Product Analysis
| Conductor Fracture | 54 |
|---|---|
| Insulation Breach | 44 |
| Crimp/Weld/Bond | 1 |
| Other | 15 |
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 |
| Serial Number Prefix | TAL |
|---|---|
| Lead Body Diameter | 10 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | 3.2 mm |
| High Voltage Connector | 6.5 mm |
| Steroid | None |
Data as of March 12, 2013