5592
CapSure SP Novus
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | at 105 mo | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.7 | 99.3 | 99.3 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | |
| # | 517 | 434 | 347 | 283 | 219 | 153 | 111 | 81 | 54 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 672 |
|---|---|
| Cumulative Months of Follow-Up | 31062 |
| Number of Leads Active in Study | 112 |
5
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Lead Dislodgement | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 2 |
| Lead Dislodgement | 24 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Registered USA Implants | 34543 |
| Estimated Active USA Implants | 18944 |
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Estimated WW Distribution | 102111 |
USA Returned Product Analysis
| Conductor Fracture | 4 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 4 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
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 | LEU |
|---|---|
| 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