Home > Leads > Defibrillation
6936, 6966 Transvene |
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|
Product Characteristics |
| US Market Release |
Dec-93 |
|
Serial Number Prefix |
TAV or TAL |
| Registered US Implants |
23,700 |
|
Type and/or Fixation |
Transvenous, Vent, Defib and
Pace/Sense, Screw-in |
| Estimated Active US Implants |
3,200 |
|
Polarity |
True Bipolar/One Coil |
| Advisories |
None |
|
Steroid |
No |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Implant Damage |
90 |
| Electrical Malfunction |
487 |
| Other |
19 |
|
| Number of Leads Enrolled in Study |
1,350 |
| Cumulative Months of Follow-Up |
67,840 |
| Number of Leads Active in Study |
40 |
| |
|
| Qualifying Complications |
150 Total |
|
| Conductor Fracture |
18 |
|
| Extra Cardiac Stimulation |
2 |
|
| Failure to Capture |
9 |
|
| Failure to Sense |
4 |
|
| Impedance Out of Range |
5 |
|
| Insulation (not further defined) |
14 |
|
| Oversensing |
93 |
|
| Unspecified Clinical Failure |
5 |
|
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