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 | 97.5 | 96.0 | 93.7 | 92.5 | 90.5 | 88.6 | 88.6 | 83.9 | 82.8 | 78.6 | 74.6 | |||||||||
| # | 807 | 704 | 615 | 511 | 429 | 346 | 283 | 221 | 149 | 107 | 74 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1019 |
|---|---|
| Cumulative Months of Follow-Up | 58381 |
| Number of Leads Active in Study | 244 |
93
Qualifying Complications
| Conductor Fracture | 26 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 29 |
| Failure to Sense | 3 |
| Impedance Out of Range | 5 |
| Insulation (not further defined) | 3 |
| Oversensing | 24 |
| Other | 1 |
Customer Communications For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 4 |
| Failure to Capture | 52 |
| Failure to Sense | 5 |
| Impedance Out of Range | 9 |
| Insulation Breach | 1 |
| Lead Dislodgement | 6 |
| Oversensing | 21 |
Distribution Data
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Registered USA Implants | 48928 |
| Estimated Active USA Implants | 30033 |
| US Market Release | 1999-09-16 |
|---|---|
| CE Approval Date | 1998-04-21 |
| Estimated WW Distribution | 166650 |
USA Returned Product Analysis
| Conductor Fracture | 102 |
|---|---|
| Insulation Breach | 52 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 128 |
|---|---|
| Insulation Breach | 65 |
| 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 November 8, 2019