Home > Leads > Defibrillation
6945 Sprint |
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|
Product Characteristics |
| US Market Release |
Sep-97 |
|
Serial Number Prefix |
TDA |
| Registered US Implants |
42,800 |
|
Type and/or Fixation |
Transvenous, Vent, Defib and
Pace/Sense, Screw-in |
| Estimated Active US Implants |
18,100 |
|
Polarity |
Integrated Bipolar/Two Coils |
| Advisories |
None |
|
Steroid |
Yes |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Implant Damage |
198 |
| Electrical Malfunction |
118 |
| Other |
11 |
|
| Number of Leads Enrolled in Study |
1,157 |
| Cumulative Months of Follow-Up |
54,899 |
| Number of Leads Active in Study |
229 |
| |
|
|
| Qualifying Complications |
27 Total |
|
| Conductor Fracture |
3 |
|
| Extra Cardiac Stimulation |
1 |
|
| Failure to Capture |
1 |
|
| Failure to Sense |
4 |
|
| Impedance Out of Range |
5 |
|
| Oversensing |
12 |
|
| Unspecified Clinical Failure |
1 |
|
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