6957 Spectraflex |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Jul-79 | Serial Number Prefix | VC | |
| Registered US Implants | 29,100 | Type and/or Fixation | Transvenous, V or A, Screw-in | |
| Estimated Active US Implants | 2,000 | Polarity | Unipolar | |
| Advisories | None | Steroid | No | |
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 673 | |||||||||
| Cumulative Months of Follow-Up | 24,255 | |||||||||
| Number of Leads Active in Study | 1 | |||||||||
| Qualifying Complications | 10 Total | |||||||||
| Extra Cardiac Stimulation | 1 | |||||||||
| Failure to Capture | 3 | |||||||||
| Failure to Sense | 5 | |||||||||
| Oversensing | 1 | |||||||||
| Ventricular Placement | ||||
|---|---|---|---|---|
| System Longevity Study Results | ||||
| Number of Leads Enrolled in Study | 1,853 | |||
| Cumulative Months of Follow-Up | 96,335 | |||
| Number of Leads Active in Study | 17 | |||
| Qualifying Complications | 42 Total | |||
| Conductor Fracture | 14 | |||
| Extra Cardiac Stimulation | 2 | |||
| Failure to Capture | 18 | |||
| Failure to Sense | 2 | |||
| Impedance Out of Range | 1 | |||
| Insulation (not further defined) | 1 | |||
| Oversensing | 4 | |||
