5024M
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 | 17 yr | at 207 mo | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.6 | 99.5 | 99.4 | 99.3 | 99.3 | 99.1 | 99.0 | 98.9 | 98.8 | 98.5 | 98.5 | 98.3 | 97.9 | 97.1 | 97.1 | 95.6 | 95.6 | |||
| # | 6128 | 5277 | 4477 | 3747 | 3113 | 2460 | 1927 | 1457 | 1103 | 837 | 636 | 466 | 348 | 250 | 163 | 102 | 56 | 48 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 8153 |
|---|---|
| Cumulative Months of Follow-Up | 444024 |
| Number of Leads Active in Study | 262 |
57
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Extra Cardiac Stimulation | 2 |
| Failure to Capture | 27 |
| Failure to Sense | 2 |
| Impedance Out of Range | 3 |
| Insulation (ESC) | 1 |
| Insulation (not further defined) | 5 |
| Lead Dislodgement | 6 |
| Oversensing | 5 |
| Other | 2 |
| Unspecified Clinical Failure | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 9 |
|---|---|
| Conductor Fracture | 8 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 49 |
| Failure to Sense | 9 |
| Impedance Out of Range | 3 |
| Insulation Breach | 6 |
| Lead Dislodgement | 30 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 16 |
Distribution Data
| US Market Release | 1991-02-01 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 197022 |
| Estimated Active USA Implants | 42313 |
| US Market Release | 1991-02-01 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 231668 |
USA Returned Product Analysis
| Conductor Fracture | 53 |
|---|---|
| Insulation Breach | 55 |
| Crimp/Weld/Bond | 0 |
| Other | 17 |
WW Returned Product Analysis
| Conductor Fracture | 57 |
|---|---|
| Insulation Breach | 58 |
| Crimp/Weld/Bond | 7 |
| Other | 51 |
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 | LAT |
|---|---|
| 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