5092
CapSure SP Novus
ALL
Device Survival Probability
5092_SURV
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| 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 | at 162.0 mo | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.5 | 99.3 | 99.2 | 98.9 | 98.9 | 98.6 | 98.6 | 98.6 | 98.6 | 98.6 | 97.8 | 97.8 | 97.8 | 97.8 | |||||||
| # | 814 | 652 | 517 | 421 | 335 | 264 | 218 | 173 | 149 | 131 | 109 | 81 | 56 | 52 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1216 |
|---|---|
| Cumulative Months of Follow-Up | 54448 |
| Number of Leads Active in Study | 21 |
10
Qualifying Complications
| Extra Cardiac Stimulation | 1 |
|---|---|
| Failure to Capture | 3 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 5 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 7 |
|---|---|
| Conductor Fracture | 3 |
| Extra Cardiac Stimulation | 3 |
| Failure to Capture | 49 |
| Failure to Sense | 7 |
| Impedance Out of Range | 1 |
| Insulation Breach | 3 |
| Lead Dislodgement | 72 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 8 |
Distribution Data
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Registered USA Implants | 141700 |
| Estimated Active USA Implants | 29515 |
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Estimated WW Distribution | 468888 |
USA Returned Product Analysis
| Conductor Fracture | 27 |
|---|---|
| Insulation Breach | 71 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 27 |
|---|---|
| Insulation Breach | 75 |
| Crimp/Weld/Bond | 0 |
| Other | 5 |
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 | Yes |
Data as of May 10, 2023