5092
CapSure SP Novus
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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.4 | 99.2 | 99.0 | 99.0 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 |
| # | 812 | 650 | 518 | 407 | 316 | 240 | 179 | 123 | 79 | 52 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1172 |
|---|---|
| Cumulative Months of Follow-Up | 47860 |
| Number of Leads Active in Study | 130 |
9
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 2 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 5 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 4 |
|---|---|
| Conductor Fracture | 1 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 30 |
| Failure to Sense | 6 |
| Insulation Breach | 3 |
| Lead Dislodgement | 43 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 9 |
Distribution Data
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Registered USA Implants | 132748 |
| Estimated Active USA Implants | 60768 |
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Estimated WW Distribution | 353308 |
USA Returned Product Analysis
| Conductor Fracture | 10 |
|---|---|
| Insulation Breach | 38 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
WW Returned Product Analysis
| Conductor Fracture | 10 |
|---|---|
| Insulation Breach | 40 |
| Crimp/Weld/Bond | 0 |
| Other | 16 |
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 | LET |
|---|---|
| Lead Body Diameter | 6.0 FR |
| Insulation | Silicone |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Steroid |
Data as of March 12, 2013