Home > Leads > Epi/Myocardial
4968 CapSure Epi |
|
|
Product Characteristics |
| US Market Release |
Sep-99 |
|
Serial Number Prefix |
LEN |
| Registered US Implants |
16,000 |
|
Type and/or Fixation |
Epicardial Suture-On V or A |
| Estimated Active US Implants |
10,000 |
|
Polarity |
Bipolar |
| Advisories |
None |
|
Steroid |
Yes |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Implant Damage |
2 |
| Electrical Malfunction |
11 |
| Other |
0 |
|
| Number of Leads Enrolled in Study |
543 |
| Cumulative Months of Follow-Up |
22,604 |
| Number of Leads Active in Study |
326 |
| |
|
|
| Qualifying Complications |
34 Total |
|
| Conductor Fracture |
7 |
|
| Failure to Capture |
14 |
|
| Failure to Sense |
3 |
|
| Impedance Out of Range |
4 |
|
| Insulation (not further defined) |
2 |
|
| Oversensing |
4 |
|
