5594
CapSure SP Novus
ALL
Device Survival Probability
| at 0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 20 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 20 |
|---|---|
| Cumulative Months of Follow-Up | 1515 |
| Number of Leads Active in Study | 10 |
0
Qualifying Complications
| Cardiac Perforation | 0 |
|---|---|
| Conductor Fracture | 0 |
| Electrical Abandonment | 0 |
| Extra Cardiac Stimulation | 0 |
| Failure to Capture | 0 |
| Failure to Sense | 0 |
| Impedance Out of Range | 0 |
| Insulation (ESC) | 0 |
| Insulation (MIO) | 0 |
| Insulation (not further defined) | 0 |
| Lead Dislodgement | 0 |
| Medical Judgement | 0 |
| Oversensing | 0 |
| Other | 0 |
| Unspecified Clinical Failure | 0 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Lead Dislodgement | 8 |
|---|---|
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2001-06-25 |
|---|---|
| CE Approval Date | 2001-03-23 |
| Registered USA Implants | 15765 |
| Estimated Active USA Implants | 10258 |
| US Market Release | 2001-06-25 |
|---|---|
| CE Approval Date | 2001-03-23 |
| Estimated WW Distribution | 47860 |
USA Returned Product Analysis
| Conductor Fracture | 5 |
|---|---|
| Insulation Breach | 7 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 8 |
|---|---|
| Insulation Breach | 7 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
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 | LFD |
|---|---|
| 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