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 | at 114.0 mo | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.1 | 99.1 | 99.1 | 98.2 | 95.3 | 94.3 | 93.1 | 91.8 | 89.0 | 89.0 | |||||||||||
| # | 117 | 113 | 110 | 104 | 92 | 82 | 76 | 69 | 55 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 122 |
|---|---|
| Cumulative Months of Follow-Up | 13652 |
| Number of Leads Active in Study | 11 |
14
Qualifying Complications
| Conductor Fracture | 5 |
|---|---|
| Failure to Capture | 0 |
| Impedance Out of Range | 1 |
| Insulation (not further defined) | 2 |
| Lead Dislodgement | 1 |
| Other | 1 |
| Unspecified Clinical Failure | 4 |
Customer Communications 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 | 2606 |
| Estimated Active USA Implants | 1554 |
| US Market Release | 2001-04-06 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 3679 |
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 November 8, 2019