4092
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 | ||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.9 | 98.8 | 98.7 | 98.4 | 98.1 | 97.7 | 97.7 | 97.7 | 97.7 | 97.7 |
| # | 929 | 831 | 734 | 637 | 553 | 449 | 320 | 206 | 117 | 47 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 1147 |
|---|---|
| Cumulative Months of Follow-Up | 65701 |
| Number of Leads Active in Study | 293 |
19
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 9 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 4 |
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 | 4 |
| Failure to Capture | 28 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 21 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 1998-09-17 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Registered USA Implants | 176993 |
| Estimated Active USA Implants | 80383 |
| US Market Release | 1998-09-17 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Estimated WW Distribution | 424896 |
USA Returned Product Analysis
| Conductor Fracture | 9 |
|---|---|
| Insulation Breach | 48 |
| Crimp/Weld/Bond | 0 |
| Other | 3 |
WW Returned Product Analysis
| Conductor Fracture | 9 |
|---|---|
| Insulation Breach | 52 |
| Crimp/Weld/Bond | 0 |
| Other | 10 |
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 | LEP |
|---|---|
| Lead Body Diameter | 5.3 FR |
| Insulation | Polyurethane (outer) Silicone (inner) |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013