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 | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.4 | 97.5 | 96.0 | 94.3 | 93.1 | 91.1 | 89.3 | 89.1 | 85.0 | 83.9 | 80.6 | 77.9 | 75.1 | 72.3 | 71.3 | ||||||
| # | 824 | 742 | 662 | 572 | 509 | 434 | 384 | 321 | 239 | 198 | 162 | 122 | 88 | 69 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1053 |
|---|---|
| Cumulative Months of Follow-Up | 70996 |
| Number of Leads Active in Study | 186 |
106
Qualifying Complications
| Conductor Fracture | 33 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 29 |
| 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 | 97 |
| Failure to Sense | 12 |
| Impedance Out of Range | 21 |
| Insulation Breach | 1 |
| Lead Dislodgement | 8 |
| Oversensing | 31 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 62709 |
| Estimated Active USA Implants | 34288 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 225654 |
USA Returned Product Analysis
| Conductor Fracture | 150 |
|---|---|
| Insulation Breach | 84 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 188 |
|---|---|
| Insulation Breach | 105 |
| 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 April 30, 2024