6936, 6966 Transvene |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Dec-93 | Serial Number Prefix | TAV or TAL | |
| Registered US Implants | 23,600 | Type and/or Fixation | Transvenous, Vent, Defib and Pace/Sense, Screw-in |
|
| Estimated Active US Implants | 3,100 | Polarity | True Bipolar/One Coil | |
| Advisories | None | Steroid | No |
| System Longevity Study Results |
|
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Leads Enrolled in Study | 1,348 | |||||||||||||
| Cumulative Months of Follow-Up | 69,593 | |||||||||||||
| Number of Leads Active in Study | 38 | |||||||||||||
| Qualifying Complications | 192 Total | |||||||||||||
| Conductor Fracture | 22 | |||||||||||||
| Extra Cardiac Stimulation | 7 | |||||||||||||
| Failure to Capture | 18 | |||||||||||||
| Failure to Sense | 5 | |||||||||||||
| Impedance Out of Range | 8 | |||||||||||||
| Insulation (not further defined) | 13 | |||||||||||||
| Oversensing | 114 | |||||||||||||
| Unspecified Clinical Failure | 5 | |||||||||||||
