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 | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 97.3 | 95.7 | 94.0 | 92.8 | 90.7 | 89.0 | 88.5 | 84.1 | 82.9 | 79.4 | 76.0 | 71.6 | 68.1 | |||||||
| # | 817 | 732 | 655 | 563 | 495 | 416 | 357 | 295 | 218 | 176 | 127 | 97 | 67 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1053 |
|---|---|
| Cumulative Months of Follow-Up | 67181 |
| Number of Leads Active in Study | 185 |
108
Qualifying Complications
| Conductor Fracture | 30 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 34 |
| Failure to Sense | 3 |
| Impedance Out of Range | 5 |
| Insulation (not further defined) | 4 |
| Lead Dislodgement | 1 |
| Oversensing | 26 |
| 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 | 84 |
| Failure to Sense | 9 |
| Impedance Out of Range | 20 |
| Insulation Breach | 1 |
| Lead Dislodgement | 7 |
| Oversensing | 30 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 60048 |
| Estimated Active USA Implants | 32808 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 213880 |
USA Returned Product Analysis
| Conductor Fracture | 135 |
|---|---|
| Insulation Breach | 71 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 169 |
|---|---|
| Insulation Breach | 90 |
| 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 May 10, 2023