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 | 97.7 | 96.2 | 93.9 | 92.7 | 90.9 | 89.1 | 89.1 | 84.6 | 83.4 | 78.8 | 77.7 | |||||||||
| # | 769 | 677 | 593 | 490 | 419 | 336 | 269 | 203 | 138 | 94 | 67 | 58 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1001 |
|---|---|
| Cumulative Months of Follow-Up | 55777 |
| Number of Leads Active in Study | 257 |
86
Qualifying Complications
| Conductor Fracture | 24 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 27 |
| Failure to Sense | 3 |
| Impedance Out of Range | 5 |
| 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 | 3 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 42 |
| Failure to Sense | 2 |
| Impedance Out of Range | 6 |
| Insulation Breach | 1 |
| Lead Dislodgement | 6 |
| Oversensing | 17 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 45617 |
| Estimated Active USA Implants | 28010 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 153102 |
USA Returned Product Analysis
| Conductor Fracture | 91 |
|---|---|
| Insulation Breach | 49 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 112 |
|---|---|
| Insulation Breach | 58 |
| 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 12, 2018