4092
CapSure SP Novus
ALL
Device Survival Probability
4092_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 | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.8 | 98.7 | 98.5 | 98.1 | 97.8 | 97.4 | 97.4 | 97.4 | 97.4 | 97.4 | 97.4 | 97.4 | |||||||||
| # | 921 | 822 | 734 | 629 | 515 | 402 | 333 | 279 | 238 | 157 | 93 | 56 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 1201 |
|---|---|
| Cumulative Months of Follow-Up | 70037 |
| Number of Leads Active in Study | 15 |
21
Qualifying Complications
| Conductor Fracture | 3 |
|---|---|
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 12 |
| Impedance Out of Range | 1 |
| Lead Dislodgement | 4 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 4 |
|---|---|
| Conductor Fracture | 4 |
| Extra Cardiac Stimulation | 1 |
| Failure to Capture | 35 |
| Impedance Out of Range | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 35 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1998-09-17 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Registered USA Implants | 186233 |
| Estimated Active USA Implants | 36641 |
| US Market Release | 1998-09-17 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Estimated WW Distribution | 567956 |
USA Returned Product Analysis
| Conductor Fracture | 20 |
|---|---|
| Insulation Breach | 98 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 20 |
|---|---|
| Insulation Breach | 106 |
| 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 | 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 May 10, 2023