5524M
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 | 11 yr | 12 yr | 13 yr | 14 yr | 15 yr | 16 yr | at 195 mo | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.7 | 99.5 | 99.3 | 99.2 | 99.2 | 98.9 | 98.4 | 98.1 | 97.8 | 97.6 | 97.6 | 97.6 | 97.0 | 96.2 | 96.2 | 96.2 | ||||
| # | 3438 | 2964 | 2541 | 2136 | 1781 | 1418 | 1120 | 862 | 691 | 556 | 422 | 311 | 233 | 170 | 102 | 53 | 49 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 4496 |
|---|---|
| Cumulative Months of Follow-Up | 255338 |
| Number of Leads Active in Study | 233 |
41
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Failure to Capture | 23 |
| Failure to Sense | 4 |
| Impedance Out of Range | 1 |
| Insulation (not further defined) | 1 |
| Lead Dislodgement | 4 |
| Oversensing | 6 |
| Other | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Conductor Fracture | 2 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 12 |
| Failure to Sense | 9 |
| Insulation Breach | 2 |
| Lead Dislodgement | 20 |
| Unspecified Clinical Failure | 10 |
Distribution Data
| US Market Release | 1992-01-01 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 58941 |
| Estimated Active USA Implants | 15656 |
| US Market Release | 1992-01-01 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 66014 |
USA Returned Product Analysis
| Conductor Fracture | 11 |
|---|---|
| Insulation Breach | 11 |
| Crimp/Weld/Bond | 1 |
| Other | 3 |
WW Returned Product Analysis
| Conductor Fracture | 11 |
|---|---|
| Insulation Breach | 11 |
| Crimp/Weld/Bond | 1 |
| Other | 8 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | Tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LAV |
|---|---|
| Lead Body Diameter | 7.8 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Steroid |
Data as of March 12, 2013