4968
CapSure EPI
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 117 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.6 | 96.7 | 95.1 | 93.0 | 92.1 | 91.2 | 89.2 | 89.2 | 86.4 | 84.7 |
| # | 618 | 525 | 428 | 342 | 266 | 195 | 142 | 99 | 66 | 47 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 816 |
|---|---|
| Cumulative Months of Follow-Up | 39078 |
| Number of Leads Active in Study | 334 |
61
Qualifying Complications
| Conductor Fracture | 12 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 20 |
| Failure to Sense | 4 |
| Impedance Out of Range | 5 |
| Insulation (not further defined) | 3 |
| Oversensing | 8 |
| Other | 7 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Failure to Capture | 11 |
|---|---|
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 3 |
| Oversensing | 2 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 27775 |
| Estimated Active USA Implants | 17196 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 87582 |
USA Returned Product Analysis
| Conductor Fracture | 33 |
|---|---|
| Insulation Breach | 12 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
WW Returned Product Analysis
| Conductor Fracture | 40 |
|---|---|
| Insulation Breach | 16 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
Product Characteristics
| Lead Type | Epi/Myocardial |
|---|---|
| Type and/or Fixation | Suture |
| Lead Function | Pacing/Sensing |
| Lead Placement | Myocardial |
| Lead Tip Location | Myocardial |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LEN |
|---|---|
| Lead Body Diameter | 7.8 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013