4524
CapSure SP
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | 10 yr | at 126 mo | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.3 | 99.3 | 99.0 | 99.0 | 99.0 | 99.0 | 99.0 | 99.0 | 99.0 | 99.0 | ||||||||||
| # | 682 | 537 | 427 | 329 | 251 | 182 | 133 | 87 | 65 | 55 | 51 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 911 |
|---|---|
| Cumulative Months of Follow-Up | 40725 |
| Number of Leads Active in Study | 35 |
6
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Failure to Sense | 2 |
| Lead Dislodgement | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 2 |
|---|---|
| Conductor Fracture | 2 |
| Failure to Capture | 15 |
| Failure to Sense | 4 |
| Impedance Out of Range | 1 |
| Insulation Breach | 2 |
| Lead Dislodgement | 23 |
| Unspecified Clinical Failure | 12 |
Distribution Data
| US Market Release | 1991-10-01 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 99496 |
| Estimated Active USA Implants | 23438 |
| US Market Release | 1991-10-01 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 125065 |
USA Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 64 |
| Crimp/Weld/Bond | 0 |
| Other | 6 |
WW Returned Product Analysis
| Conductor Fracture | 1 |
|---|---|
| Insulation Breach | 65 |
| Crimp/Weld/Bond | 0 |
| Other | 14 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | J-Shape, tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LAR |
|---|---|
| Lead Body Diameter | 6.2 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013