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 | 10 yr | 11 yr | 12 yr | at 150.0 mo | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.3 | 99.3 | 99.2 | 99.0 | 98.8 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | ||||||||
| # | 1365 | 1048 | 819 | 651 | 528 | 450 | 377 | 310 | 240 | 169 | 115 | 65 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1777 |
|---|---|
| Cumulative Months of Follow-Up | 84545 |
| Number of Leads Active in Study | 653 |
15
Qualifying Complications
| Conductor Fracture | 2 |
|---|---|
| Failure to Capture | 6 |
| Lead Dislodgement | 7 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 4 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 187 |
| Failure to Sense | 91 |
| Impedance Out of Range | 12 |
| Lead Dislodgement | 290 |
| Oversensing | 18 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 124110 |
| Estimated Active USA Implants | 71424 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 946343 |
USA Returned Product Analysis
| Conductor Fracture | 14 |
|---|---|
| Insulation Breach | 26 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 19 |
|---|---|
| Insulation Breach | 29 |
| 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 November 20, 2024