6949 Sprint Fidelis |
Product Characteristics | ||||
|---|---|---|---|---|---|
| US Market Release | Sep-04 | Serial Number Prefix | LFJ | ||
| Registered US Implants | 186,700 | Type and/or Fixation | Transvenous, Vent, Defib and Pace/ Sense, Screw-in |
||
| Estimated Active US Implants | 129,700 | Polarity | True Bipolar/Two Coils | ||
| Steroid | Yes | ||||
| Advisories | 1 | 2007 Potential Conductor Wire Fracture | |||
| System Longevity Study Results |
|
|||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Number of Leads Enrolled in Study | 795 | |||||||||||||
| Cumulative Months of Follow-Up | 25,547 | |||||||||||||
| Number of Leads Active in Study | 536 | |||||||||||||
| Qualifying Complications | 31 Total | |||||||||||||
| Conductor Fracture | 10 | |||||||||||||
| Failure to Capture | 2 | |||||||||||||
| Failure to Sense | 2 | |||||||||||||
| Impedance Out of Range | 5 | |||||||||||||
| Insulation (not further defined) | 1 | |||||||||||||
| Lead Dislodgement | 1 | |||||||||||||
| Oversensing | 10 | |||||||||||||
