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 | at 138.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 97.6 | 96.4 | 94.0 | 92.8 | 90.9 | 89.1 | 89.1 | 84.4 | 83.2 | 78.5 | 77.3 | |||||||||
| # | 763 | 669 | 579 | 488 | 414 | 322 | 259 | 199 | 137 | 96 | 63 | 54 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 990 |
|---|---|
| Cumulative Months of Follow-Up | 54706 |
| Number of Leads Active in Study | 261 |
84
Qualifying Complications
| Conductor Fracture | 23 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 27 |
| Failure to Sense | 3 |
| Impedance Out of Range | 4 |
| Insulation (not further defined) | 3 |
| Oversensing | 21 |
| Other | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 40 |
| Failure to Sense | 2 |
| Impedance Out of Range | 5 |
| Insulation Breach | 1 |
| Lead Dislodgement | 6 |
| Oversensing | 14 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 44028 |
| Estimated Active USA Implants | 27021 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 147293 |
USA Returned Product Analysis
| Conductor Fracture | 87 |
|---|---|
| Insulation Breach | 47 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 103 |
|---|---|
| Insulation Breach | 56 |
| 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 January 31, 2018