Home > Leads > Defibrillation
6933, 6937, 6937A, 6963 SVC/CS |
|
Product Characteristics |
| US Market Release |
Dec-93 |
|
Serial Number Prefix |
TAT, TBU, or TAF |
| Registered US Implants |
16,800 |
|
Type and/or Fixation |
Transvenous CS or SVC Defib |
| Estimated Active US Implants |
2,600 |
|
Polarity |
One Defib Coil |
| Advisories |
None |
|
Steroid |
No |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Conductor Fracture |
166 |
| Crimp/Weld/Bond |
0 |
| Insulation Breach |
32 |
| Extrinsic |
31 |
| Other |
16 |
|
| Number of Leads Enrolled in Study |
966 |
| Cumulative Months of Follow-Up |
49,684 |
| Number of Leads Active in Study |
34 |
| |
|
| Qualifying Complications |
54 Total |
|
| Conductor Fracture |
17 |
|
| Extra Cardiac Stimulation |
5 |
|
| Failure to Capture |
8 |
|
| Failure to Sense |
1 |
|
| Impedance out of Range |
4 |
|
| Lead Dislodgement |
1 |
|
| Insulation (not further defined) |
2 |
|
| Oversensing |
12 |
|
| Unspecified Clinical Failure |
4 |
|
