6937A
Transvene SVC-CS
ALL
Device Survival Probability
6933_6937_6937A_6963_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 | at 126.0 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.4 | 97.5 | 97.2 | 96.7 | 95.4 | 94.9 | 93.9 | 93.4 | 92.2 | 91.1 | 91.1 | ||||||||||
| # | 826 | 693 | 579 | 487 | 386 | 310 | 217 | 168 | 109 | 71 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 972 |
|---|---|
| Cumulative Months of Follow-Up | 54349 |
| Number of Leads Active in Study | 10 |
48
Qualifying Complications
| Conductor Fracture | 16 |
|---|---|
| Extra Cardiac Stimulation | 4 |
| Failure to Capture | 6 |
| Failure to Sense | 1 |
| Impedance Out of Range | 3 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 1 |
| Oversensing | 10 |
| Other | 1 |
| Unspecified Clinical Failure | 4 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Conductor Fracture | 3 |
|---|---|
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2001-04-06 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 2297 |
| Estimated Active USA Implants | 1351 |
| US Market Release | 2001-04-06 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 3274 |
USA Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 0 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Passive |
| Lead Function | Defibrillation Electrode |
| Lead Placement | Transvenous |
| Lead Tip Location | SVC/CS |
| Pace/Sense Polarity | One Coil |
| Serial Number Prefix | TDB |
|---|---|
| Lead Body Diameter | 7.5 FR |
| Insulation | Silicone with Polyurethane Overlay |
| Pace/Sense Connector Style | n/a |
| High Voltage Connector | DF-1 |
| Steroid | None |
Data as of February 3, 2017