4965
CapSure Epi
ALL
Device Survival Probability
4965_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.6 | 96.8 | 95.7 | 87.1 | ||||||
| # | 131 | 112 | 91 | 67 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 232 |
|---|---|
| Cumulative Months of Follow-Up | 7216 |
| Number of Leads Active in Study | 5 |
16
Qualifying Complications
| Conductor Fracture | 9 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 1 |
| Insulation (not further defined) | 1 |
| Oversensing | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 6 |
| Failure to Sense | 5 |
| Impedance Out of Range | 13 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 1996-09-06 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 23159 |
| Estimated Active USA Implants | 8569 |
| US Market Release | 1996-09-06 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 55233 |
USA Returned Product Analysis
| Conductor Fracture | 263 |
|---|---|
| Insulation Breach | 53 |
| Crimp/Weld/Bond | 1 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 316 |
|---|---|
| Insulation Breach | 60 |
| Crimp/Weld/Bond | 1 |
| Other | 3 |
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 | Unipolar |
| Serial Number Prefix | LBT |
|---|---|
| Lead Body Diameter | 4.5 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 UNI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of October 12, 2018