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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 97.4 | 95.9 | 94.1 | 93.0 | 90.6 | 88.8 | 88.8 | 84.0 | 83.0 | 79.6 | 75.5 | 71.2 | ||||||||
| # | 803 | 719 | 630 | 536 | 460 | 378 | 321 | 273 | 190 | 147 | 106 | 83 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1032 |
|---|---|
| Cumulative Months of Follow-Up | 62657 |
| Number of Leads Active in Study | 204 |
99
Qualifying Complications
| Conductor Fracture | 27 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 30 |
| Failure to Sense | 3 |
| Impedance Out of Range | 5 |
| Insulation (not further defined) | 4 |
| Lead Dislodgement | 1 |
| Oversensing | 25 |
| Other | 2 |
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 | 6 |
| Failure to Capture | 68 |
| Failure to Sense | 8 |
| Impedance Out of Range | 13 |
| Insulation Breach | 1 |
| Lead Dislodgement | 7 |
| Oversensing | 28 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 54845 |
| Estimated Active USA Implants | 29632 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 195032 |
USA Returned Product Analysis
| Conductor Fracture | 123 |
|---|---|
| Insulation Breach | 67 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 156 |
|---|---|
| Insulation Breach | 83 |
| 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 October 11, 2021