4968
CapSure Epi
ALL
Device Survival Probability
4968_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | 11 yr | 12 yr | 13 yr | 14 yr | 15 yr | 16 yr | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 97.6 | 96.1 | 94.3 | 93.1 | 91.1 | 89.4 | 88.9 | 85.0 | 83.7 | 79.3 | 76.9 | 73.3 | 70.7 | 70.0 | 68.9 | |||||
| # | 828 | 750 | 677 | 586 | 518 | 448 | 403 | 349 | 275 | 234 | 180 | 155 | 128 | 100 | 74 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1059 |
|---|---|
| Cumulative Months of Follow-Up | 75826 |
| Number of Leads Active in Study | 160 |
113
Qualifying Complications
| Conductor Fracture | 37 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 30 |
| Failure to Sense | 3 |
| Impedance Out of Range | 5 |
| Insulation (not further defined) | 5 |
| Lead Dislodgement | 1 |
| Oversensing | 27 |
| Other | 3 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 4 |
| Extra Cardiac Stimulation | 7 |
| Failure to Capture | 122 |
| Failure to Sense | 17 |
| Impedance Out of Range | 26 |
| Insulation Breach | 1 |
| Lead Dislodgement | 8 |
| Oversensing | 36 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 68807 |
| Estimated Active USA Implants | 37744 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 254284 |
USA Returned Product Analysis
| Conductor Fracture | 160 |
|---|---|
| Insulation Breach | 106 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 198 |
|---|---|
| Insulation Breach | 130 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
Product Characteristics
| Lead Type | Epi/Myocardial |
|---|---|
| Type and/or Fixation | Suture |
| Lead Function | Pacing/Sensing |
| Lead Placement | Myocardial |
| Lead Tip Location | Atrium or Right Ventricle |
| 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 June 8, 2026