4574
CapSure Sense
ALL
Device Survival Probability
4574_SURV
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| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 114.0 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 99.2 | 99.2 | 99.0 | 98.7 | 98.7 | 98.7 | 98.7 | 98.7 | 98.7 |
| # | 962 | 748 | 604 | 467 | 345 | 251 | 188 | 116 | 64 | 53 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1276 |
|---|---|
| Cumulative Months of Follow-Up | 53137 |
| Number of Leads Active in Study | 612 |
11
Qualifying Complications
| Conductor Fracture | 2 |
|---|---|
| Failure to Capture | 2 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 7 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 84 |
| Failure to Sense | 37 |
| Impedance Out of Range | 4 |
| Lead Dislodgement | 189 |
| Oversensing | 6 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 98359 |
| Estimated Active USA Implants | 63677 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 718114 |
USA Returned Product Analysis
| Conductor Fracture | 11 |
|---|---|
| Insulation Breach | 17 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 14 |
|---|---|
| Insulation Breach | 18 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | J-shape, tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | BBE |
|---|---|
| Lead Body Diameter | 5.3 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of October 29, 2020