Home > Leads > Defibrillation
6943 Sprint |
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|
Product Characteristics |
| US Market Release |
Oct-97 |
|
Serial Number Prefix |
TCE |
| Registered US Implants |
20,800 |
|
Type and/or Fixation |
Transvenous, Vent, Defib and
Pace/Sense, Screw-in |
| Estimated Active US Implants |
8,800 |
|
Polarity |
True Bipolar/One Coil |
| Advisories |
None |
|
Steroid |
Yes |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Implant Damage |
51 |
| Electrical Malfunction |
71 |
| Other |
8 |
|
| Number of Leads Enrolled in Study |
1,311 |
| Cumulative Months of Follow-Up |
65,157 |
| Number of Leads Active in Study |
381 |
| |
|
| Qualifying Complications |
67 Total |
|
| Conductor Fracture |
15 |
|
| Failure to Capture |
7 |
|
| Failure to Sense |
5 |
|
| Impedance Out of Range |
4 |
|
| Insulation (not further defined) |
1 |
|
| Lead Dislodgement |
1 |
|
| Oversensing |
31 |
|
| Unspecified Clinical Failure |
3 |
|
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