4965
CapSure Epi
ALL
Device Survival Probability
4965_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.6 | 95.8 | 94.8 | 86.4 | ||||||
| # | 119 | 101 | 83 | 61 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 234 |
|---|---|
| Cumulative Months of Follow-Up | 7525 |
| Number of Leads Active in Study | 4 |
17
Qualifying Complications
| Conductor Fracture | 10 |
|---|---|
| Failure to Capture | 3 |
| Failure to Sense | 1 |
| Impedance Out of Range | 0 |
| Insulation (not further defined) | 1 |
| Oversensing | 2 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 1 |
| Failure to Capture | 11 |
| Failure to Sense | 7 |
| Impedance Out of Range | 21 |
| Oversensing | 2 |
| Unspecified Clinical Failure | 3 |
Distribution Data
| US Market Release | 1996-09-06 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Registered USA Implants | 24151 |
| Estimated Active USA Implants | 6970 |
| US Market Release | 1996-09-06 |
|---|---|
| CE Approval Date | 1993-01-01 |
| Estimated WW Distribution | 61784 |
USA Returned Product Analysis
| Conductor Fracture | 295 |
|---|---|
| Insulation Breach | 64 |
| Crimp/Weld/Bond | 1 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 352 |
|---|---|
| Insulation Breach | 73 |
| Crimp/Weld/Bond | 1 |
| Other | 0 |
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 May 10, 2023