4592
CapSure SP Novus
ALL
Device Survival Probability
4592_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 | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
97.7 | 97.7 | 97.7 | 97.7 | 97.0 | 97.0 | 97.0 | 96.1 | 96.1 | 96.1 | 96.1 | 94.8 | 94.8 | ||||||||
| # | 203 | 181 | 166 | 157 | 134 | 125 | 109 | 105 | 98 | 87 | 82 | 74 | 55 |
Product Surveillance Registry Results
| Number of Leads Enrolled in Study | 365 |
|---|---|
| Cumulative Months of Follow-Up | 22424 |
| Number of Leads Active in Study | 32 |
10
Qualifying Complications
| Failure to Capture | 5 |
|---|---|
| Failure to Sense | 1 |
| Impedance Out of Range | 0 |
| Lead Dislodgement | 3 |
| Other | 1 |
Customer Communications For This Model
- There are no communications for this model.
US Acute Lead Observations
| Failure to Capture | 10 |
|---|---|
| Failure to Sense | 2 |
| Insulation Breach | 1 |
| Lead Dislodgement | 37 |
| Oversensing | 2 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 1998-10-05 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Registered USA Implants | 89797 |
| Estimated Active USA Implants | 19945 |
| US Market Release | 1998-10-05 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Estimated WW Distribution | 203520 |
USA Returned Product Analysis
| Conductor Fracture | 16 |
|---|---|
| Insulation Breach | 33 |
| Crimp/Weld/Bond | 0 |
| Other | 0 |
WW Returned Product Analysis
| Conductor Fracture | 18 |
|---|---|
| Insulation Breach | 35 |
| Crimp/Weld/Bond | 0 |
| Other | 2 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | J-shape, tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LER |
|---|---|
| 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