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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 97.6 | 96.1 | 93.8 | 92.6 | 90.6 | 88.9 | 88.9 | 84.0 | 82.9 | 78.6 | 74.3 | |||||||||
| # | 791 | 702 | 605 | 501 | 425 | 343 | 275 | 218 | 143 | 104 | 74 | 50 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1015 |
|---|---|
| Cumulative Months of Follow-Up | 57407 |
| Number of Leads Active in Study | 248 |
91
Qualifying Complications
| Conductor Fracture | 25 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 28 |
| Failure to Sense | 3 |
| Impedance Out of Range | 5 |
| Insulation (not further defined) | 3 |
| Oversensing | 24 |
| 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 | 3 |
| Failure to Capture | 46 |
| Failure to Sense | 3 |
| Impedance Out of Range | 7 |
| Insulation Breach | 1 |
| Lead Dislodgement | 6 |
| Oversensing | 18 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 47263 |
| Estimated Active USA Implants | 29121 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 159187 |
USA Returned Product Analysis
| Conductor Fracture | 97 |
|---|---|
| Insulation Breach | 51 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 120 |
|---|---|
| Insulation Breach | 62 |
| 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 11, 2019