Home > Leads >
Defibrillation
6721, 6921 Epicardial Patch |
|
|
Product Characteristics |
| US Market Release |
Feb-93 |
|
Serial Number Prefix |
TBH, TBG, TBB, TAD, TAC, or TAB |
| Registered US Implants |
8,300 |
|
Type and/or Fixation |
Epicardial Defib Patch, Suture |
| Estimated Active US Implants |
1,300 |
|
Polarity |
Defib Electrode only |
| Advisories |
None |
|
Steroid |
No |
| System Longevity Study Results |
|
| US Returned Product Analysis |
| Conductor Fracture |
68 |
| Crimp/Weld/Bond |
1 |
| Insulation Breach |
10 |
| Extrinsic |
5 |
| Other |
1 |
|
| Number of Leads Enrolled in Study |
407 |
| Cumulative Months of Follow-Up |
19,854 |
| Number of Leads Active in Study |
12 |
| |
|
| Qualifying Complications |
52 Total |
|
| Conductor Fracture |
21 |
|
| Failure to Capture |
8 |
|
| Impedance Out of Range |
4 |
|
| Insulation (not further defined) |
3 |
|
| Oversensing
| 16 |
|
