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Defibrillation
6930 Sprint Fidelis |
|
|
Product Characteristics |
| US Market Release |
Sep-04 |
|
Serial Number Prefix |
LFK |
| Registered US Implants |
400 |
|
Type and/or Fixation |
Transvenous, Vent, Defib and Pace/Sense, Tines |
| Estimated Active US Implants |
200 |
|
Polarity |
True Bipolar/One Coil |
| |
|
|
Steroid |
Yes |
| Advisories |
1 |
|
2007 Potential Conductor Wire Fracture |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Conductor Fracture |
2 |
| Crimp/Weld/Bond |
0 |
| Insulation Breach |
0 |
| Extrinsic |
0 |
| Other |
0 |
|
| Number of Leads Enrolled in Study |
4 |
| Cumulative Months of Follow-Up |
107 |
| Number of Leads Active in Study |
4 |
| |
|
| Qualifying Complications |
0 Total |
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