5594
CapSure SP Novus
ALL
Device Survival Probability
5594_SURV
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| at 0.0 mo | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
100.0 | |||||||||
| # | 0 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 43 |
|---|---|
| Cumulative Months of Follow-Up | 4691 |
| Number of Leads Active in Study | 11 |
3
Qualifying Complications
| Conductor Fracture | 1 |
|---|---|
| Insulation (not further defined) | 1 |
| Oversensing | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Failure to Capture | 4 |
|---|---|
| Lead Dislodgement | 14 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 2001-06-25 |
|---|---|
| CE Approval Date | 2001-03-23 |
| Registered USA Implants | 17612 |
| Estimated Active USA Implants | 5469 |
| US Market Release | 2001-06-25 |
|---|---|
| CE Approval Date | 2001-03-23 |
| Estimated WW Distribution | 86472 |
USA Returned Product Analysis
| Conductor Fracture | 16 |
|---|---|
| Insulation Breach | 18 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 20 |
|---|---|
| Insulation Breach | 18 |
| 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 | LFD |
|---|---|
| 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 November 20, 2024