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Defibrillation
6721, 6921 Epicardial Patch |
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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 |
| Implant Damage |
5 |
| Electrical Malfunction |
80 |
| Other |
0 |
|
| Number of Leads Enrolled in Study |
407 |
| Cumulative Months of Follow-Up |
18,283 |
| Number of Leads Active in Study |
12 |
| |
|
| Qualifying Complications |
28 Total |
|
| Conductor Fracture |
20 |
|
| Failure to Capture |
2 |
|
| Impedance Out of Range |
3 |
|
| Insulation (not further defined) |
3 |
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