4024
CapSure SP
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | at 117 mo | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.9 | 99.8 | 99.8 | 99.8 | 99.8 | 99.8 | 99.8 | 99.8 | 98.8 | 98.8 |
| # | 870 | 685 | 556 | 416 | 323 | 229 | 167 | 111 | 63 | 52 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1215 |
|---|---|
| Cumulative Months of Follow-Up | 50928 |
| Number of Leads Active in Study | 13 |
4
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Insulation (not further defined) | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 12 |
|---|---|
| Conductor Fracture | 11 |
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 103 |
| Failure to Sense | 15 |
| Impedance Out of Range | 6 |
| Insulation Breach | 1 |
| Lead Dislodgement | 48 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 20 |
Distribution Data
| US Market Release | 1991-10-01 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 217472 |
| Estimated Active USA Implants | 41101 |
| US Market Release | 1991-10-01 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 277530 |
USA Returned Product Analysis
| Conductor Fracture | 27 |
|---|---|
| Insulation Breach | 178 |
| Crimp/Weld/Bond | 0 |
| Other | 16 |
WW Returned Product Analysis
| Conductor Fracture | 31 |
|---|---|
| Insulation Breach | 202 |
| Crimp/Weld/Bond | 0 |
| Other | 49 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Right Ventricle |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LAJ |
|---|---|
| Lead Body Diameter | 5.7 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013