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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.2 | 99.2 | 99.2 | 99.1 | 98.9 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | ||||||||||
| # | 1180 | 892 | 736 | 592 | 467 | 390 | 322 | 231 | 170 | 111 | 61 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1635 |
|---|---|
| Cumulative Months of Follow-Up | 71437 |
| Number of Leads Active in Study | 751 |
13
Qualifying Complications
| Conductor Fracture | 2 |
|---|---|
| Failure to Capture | 4 |
| 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 | 3 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 130 |
| Failure to Sense | 64 |
| Impedance Out of Range | 9 |
| Lead Dislodgement | 254 |
| Oversensing | 16 |
| Unspecified Clinical Failure | 4 |
Distribution Data
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Registered USA Implants | 113050 |
| Estimated Active USA Implants | 61892 |
| US Market Release | 2002-06-23 |
|---|---|
| CE Approval Date | 2002-02-01 |
| Estimated WW Distribution | 862776 |
USA Returned Product Analysis
| Conductor Fracture | 13 |
|---|---|
| Insulation Breach | 25 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 18 |
|---|---|
| Insulation Breach | 28 |
| 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 May 10, 2023