6957J Spectraflex |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Sep-80 | Serial Number Prefix | GG | |
| Registered US Implants | 30,000 | Type and/or Fixation | Transvenous, Atrial-J, Screw-in | |
| Estimated Active US Implants | 2,100 | Polarity | Unipolar | |
| Advisories | None | Steroid | No | |
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 2,348 | |||||||||
| Cumulative Months of Follow-Up | 160,447 | |||||||||
| Number of Leads Active in Study | 22 | |||||||||
| Qualifying Complications | 88 Total | |||||||||
| Conductor Fracture | 13 | |||||||||
| Extra Cardiac Stimulation | 3 | |||||||||
| Failure to Capture | 48 | |||||||||
| Failure to Sense | 14 | |||||||||
| Impedance Out of Range | 1 | |||||||||
| Insulation (ESC) | 1 | |||||||||
| Insulation (not further defined) | 3 | |||||||||
| Lead Dislodgement | 2 | |||||||||
| Oversensing | 3 | |||||||||
