Home > Leads > Defibrillation
6931 Sprint Fidelis |
|
|
Product Characteristics |
| US Market Release |
Sep-04 |
|
Serial Number Prefix |
LFL |
| Registered US Implants |
8,100 |
|
Type and/or Fixation |
Transvenous, Vent, Defib and Pace/Sense, Screw-in |
| Estimated Active US Implants |
6,000 |
|
Polarity |
True Bipolar/One Coil |
| |
|
|
Steroid |
Yes |
| Advisories |
1 |
|
2007 Potential Conductor Wire Fracture |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Implant Damage |
28 |
| Electrical Malfunction |
102 |
| Other |
0 |
|
| Number of Leads Enrolled in Study |
292 |
| Cumulative Months of Follow-Up |
6,804 |
| Number of Leads Active in Study |
228 |
| |
|
| Qualifying Complications |
11 Total |
|
| Failure to Capture |
3 |
|
| Failure to Sense |
1 |
|
| Impedance Out of Range |
2 |
|
| Lead Dislodgement |
2 |
|
| Oversensing |
3 |
|
