Home > Leads > Defibrillation
6949 Sprint Fidelis |
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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 |
135,900 |
|
Polarity |
True Bipolar/Two Coils |
| |
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|
Steroid |
Yes |
| Advisories |
1 |
|
2007 Potential Conductor Wire Fracture |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Implant Damage |
461 |
| Electrical Malfunction |
1,435 |
| Other |
45 |
|
| Number of Leads Enrolled in Study |
789 |
| Cumulative Months of Follow-Up |
21,439 |
| Number of Leads Active in Study |
576 |
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|
| Qualifying Complications |
30 Total |
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| Conductor Fracture |
9 |
|
| Failure to Capture |
2 |
|
| Failure to Sense |
2 |
|
| Impedance Out of Range |
4 |
|
| Insulation (not further defined) |
1 |
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| Lead Dislodgement |
1 |
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| Oversensing |
11 |
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