6721
Epicardial Patch
ALL
Device Survival Probability
6721_6921_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
96.6 | 94.6 | 92.1 | 91.0 | 89.3 | 84.7 | 83.3 | 83.3 | 83.3 | |
| # | 347 | 319 | 274 | 221 | 190 | 136 | 102 | 66 | 57 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 417 |
|---|---|
| Cumulative Months of Follow-Up | 24217 |
| Number of Leads Active in Study | 5 |
51
Qualifying Complications
| Conductor Fracture | 21 |
|---|---|
| Failure to Capture | 8 |
| Impedance Out of Range | 4 |
| Insulation (not further defined) | 2 |
| Other | 16 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 4 |
| Failure to Sense | 2 |
| Impedance Out of Range | 24 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 1994-03-31 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 3428 |
| Estimated Active USA Implants | 863 |
| US Market Release | 1994-03-31 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 5594 |
USA Returned Product Analysis
| Conductor Fracture | 15 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 19 |
|---|---|
| Insulation Breach | 3 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
Product Characteristics
| Lead Type | Defibrillation |
|---|---|
| Type and/or Fixation | Suture |
| Lead Function | Defibrillation Electrode |
| Lead Placement | Epi Patch |
| Lead Tip Location | Epicardial |
| Pace/Sense Polarity | n/a |
| Serial Number Prefix | TBH, TBG, TBB |
|---|---|
| Lead Body Diameter | S, M, L |
| Insulation | Silicone |
| Pace/Sense Connector Style | n/a |
| High Voltage Connector | DF-1 |
| Steroid | None |
Data as of November 20, 2024