6721
Epicardial Patch
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 111 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
96.5 | 95.0 | 92.7 | 91.9 | 90.0 | 85.1 | 83.7 | 83.7 | 83.7 | 83.7 |
| # | 330 | 301 | 256 | 209 | 176 | 132 | 95 | 66 | 56 | 50 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 407 |
|---|---|
| Cumulative Months of Follow-Up | 23303 |
| Number of Leads Active in Study | 4 |
47
Qualifying Complications
| Conductor Fracture | 21 |
|---|---|
| Failure to Capture | 8 |
| Impedance Out of Range | 4 |
| Insulation (not further defined) | 2 |
| Oversensing | 12 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Sense | 1 |
| Impedance Out of Range | 3 |
| Oversensing | 1 |
Distribution Data
| US Market Release | 1994-03-31 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 2787 |
| Estimated Active USA Implants | 1069 |
| US Market Release | 1994-03-31 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 3970 |
USA Returned Product Analysis
| Conductor Fracture | 12 |
|---|---|
| Insulation Breach | 1 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 15 |
|---|---|
| Insulation Breach | 1 |
| 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 | n/a |
| 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 March 12, 2013