4965
CapSure Epi
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | at 51 mo | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.0 | 98.2 | 97.2 | 92.7 | 91.3 | |||||
| # | 140 | 117 | 92 | 63 | 55 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 219 |
|---|---|
| Cumulative Months of Follow-Up | 7617 |
| Number of Leads Active in Study | 25 |
12
Qualifying Complications
| Conductor Fracture | 5 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 1 |
| Insulation (not further defined) | 1 |
| Oversensing | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 4 |
| Impedance Out of Range | 3 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 1996-09-06 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 20905 |
| Estimated Active USA Implants | 9427 |
| US Market Release | 1996-09-06 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 44904 |
USA Returned Product Analysis
| Conductor Fracture | 163 |
|---|---|
| Insulation Breach | 34 |
| Crimp/Weld/Bond | 1 |
| Other | 2 |
WW Returned Product Analysis
| Conductor Fracture | 203 |
|---|---|
| Insulation Breach | 38 |
| Crimp/Weld/Bond | 1 |
| Other | 5 |
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 | Unipolar |
| Serial Number Prefix | LBT |
|---|---|
| Lead Body Diameter | 4.5 FR |
| Insulation | Silicine |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013