4592
CapSure SP Novus
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
98.2 | 98.2 | 98.2 | 98.2 | 97.4 | 97.4 | 97.4 | 96.0 | 96.0 | |
| # | 193 | 171 | 153 | 130 | 112 | 101 | 81 | 66 | 48 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 283 |
|---|---|
| Cumulative Months of Follow-Up | 14710 |
| Number of Leads Active in Study | 61 |
6
Qualifying Complications
| Failure to Capture | 3 |
|---|---|
| Failure to Sense | 1 |
| Lead Dislodgement | 2 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Failure to Capture | 8 |
|---|---|
| Failure to Sense | 1 |
| Insulation Breach | 1 |
| Lead Dislodgement | 26 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 2 |
Distribution Data
| US Market Release | 1998-10-05 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Registered USA Implants | 85431 |
| Estimated Active USA Implants | 40834 |
| US Market Release | 1998-10-05 |
|---|---|
| CE Approval Date | 1998-04-15 |
| Estimated WW Distribution | 180526 |
USA Returned Product Analysis
| Conductor Fracture | 7 |
|---|---|
| Insulation Breach | 17 |
| Crimp/Weld/Bond | 0 |
| Other | 1 |
WW Returned Product Analysis
| Conductor Fracture | 7 |
|---|---|
| Insulation Breach | 17 |
| Crimp/Weld/Bond | 0 |
| Other | 4 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | J-shape, tines |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| 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 March 12, 2013