6943 Sprint |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Oct-97 | Serial Number Prefix | TCE | |
| Registered US Implants | 20,800 | Type and/or Fixation | Transvenous, Vent, Defib and Pace/Sense, Screw-in |
|
| Estimated Active US Implants | 8,500 | Polarity | True Bipolar/One Coil | |
| Advisories | None | Steroid | Yes | |
| System Longevity Study Results |
|
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Leads Enrolled in Study | 1,311 | |||||||||||||
| Cumulative Months of Follow-Up | 72,535 | |||||||||||||
| Number of Leads Active in Study | 341 | |||||||||||||
| Qualifying Complications | 78 Total | |||||||||||||
| Conductor Fracture | 15 | |||||||||||||
| Failure to Capture | 11 | |||||||||||||
| Failure to Sense | 6 | |||||||||||||
| Impedance Out of Range | 6 | |||||||||||||
| Insulation (not further defined) | 1 | |||||||||||||
| Lead Dislodgement | 1 | |||||||||||||
| Oversensing | 35 | |||||||||||||
| Unspecified Clinical Failure | 3 | |||||||||||||
