Home > Leads > Defibrillation
6939, 6999 Sub-Q Patch |
|
|
Product Characteristics |
| US Market Release |
Dec-93 |
|
Serial Number Prefix |
TBA or TAP |
| Registered US Implants |
3,600 |
|
Type and/or Fixation |
Subcutaneous Defib Patch, Suture |
| Estimated Active US Implants |
300 |
|
Polarity |
Defib Electrode Only |
| Advisories |
None |
|
Steroid |
No |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Conductor Fracture |
28 |
| Crimp/Weld/Bond |
0 |
| Insulation Breach |
5 |
| Extrinsic |
4 |
| Other |
1 |
|
| Number of Leads Enrolled in Study |
384 |
| Cumulative Months of Follow-Up |
18,043 |
| Number of Leads Active in Study |
4 |
| |
|
| Qualifying Complications |
47 Total |
|
| Conductor Fracture |
12 |
|
| Extra Cardiac Stimulation |
5 |
|
| Failure to Capture |
11 |
|
| Failure to Sense |
1 |
|
| Impedance Out of Range |
2 |
|
| Insulation (not further defined) |
4 |
|
| Oversensing |
10 |
|
| Unspecified Clinical Failure |
2 |
|
