5592
CapSure SP Novus
ALL
Device Survival Probability
5592_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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
99.6 | 99.2 | 99.2 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | 98.9 | ||||||||
| # | 523 | 432 | 351 | 299 | 249 | 197 | 169 | 154 | 126 | 111 | 97 | 69 | 51 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 721 |
|---|---|
| Cumulative Months of Follow-Up | 39165 |
| Number of Leads Active in Study | 38 |
5
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Impedance Out of Range | 0 |
| Lead Dislodgement | 2 |
| Other | 0 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Cardiac Perforation | 1 |
|---|---|
| Failure to Capture | 4 |
| Failure to Sense | 3 |
| Lead Dislodgement | 43 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Registered USA Implants | 37334 |
| Estimated Active USA Implants | 9992 |
| US Market Release | 1998-06-03 |
|---|---|
| CE Approval Date | 1997-09-25 |
| Estimated WW Distribution | 131287 |
USA Returned Product Analysis
| Conductor Fracture | 6 |
|---|---|
| Insulation Breach | 7 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 8 |
|---|---|
| Insulation Breach | 7 |
| 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 | Yes |
Data as of May 10, 2023