4568
CapSureFix
ALL
Device Survival Probability
| 1 yr | 2 yr | 3 yr | 4 yr | 5 yr | 6 yr | 7 yr | 8 yr | 9 yr | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| % |  |
96.8 | 96.4 | 95.3 | 94.7 | 94.0 | 94.0 | 92.8 | 92.1 | 90.5 | |
| # | 495 | 431 | 350 | 292 | 242 | 187 | 134 | 80 | 51 |
System Longevity Study Results
| Number of Leads Enrolled in Study | 656 |
|---|---|
| Cumulative Months of Follow-Up | 32177 |
| Number of Leads Active in Study | 133 |
35
Qualifying Complications
| Failure to Capture | 18 |
|---|---|
| Failure to Sense | 4 |
| Impedance Out of Range | 3 |
| Lead Dislodgement | 9 |
| Medical Judgement | 1 |
Advisories For This Model
- There are no advisories for this model.
Performance Notes For This Model
US Acute Lead Observations
| Cardiac Perforation | 3 |
|---|---|
| Conductor Fracture | 1 |
| Failure to Capture | 6 |
| Failure to Sense | 1 |
| Impedance Out of Range | 2 |
| Lead Dislodgement | 4 |
| Oversensing | 1 |
| Unspecified Clinical Failure | 1 |
Distribution Data
| US Market Release | 1997-01-02 |
|---|---|
| CE Approval Date | |
| Registered USA Implants | 69137 |
| Estimated Active USA Implants | 21496 |
| US Market Release | 1997-01-02 |
|---|---|
| CE Approval Date | |
| Estimated WW Distribution | 92146 |
USA Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 81 |
| Crimp/Weld/Bond | 0 |
| Other | 53 |
WW Returned Product Analysis
| Conductor Fracture | 3 |
|---|---|
| Insulation Breach | 83 |
| Crimp/Weld/Bond | 0 |
| Other | 131 |
Product Characteristics
| Lead Type | Pacing |
|---|---|
| Type and/or Fixation | J-shape, screw in |
| Lead Function | Pacing/Sensing |
| Lead Placement | Transvenous |
| Lead Tip Location | Atrium - J |
| Pace/Sense Polarity | Bipolar |
| Serial Number Prefix | LDD |
|---|---|
| Lead Body Diameter | 7.5 FR |
| Insulation | Polyurethane |
| Pace/Sense Connector Style | IS-1 BI |
| High Voltage Connector | n/a |
| Steroid | Yes |
Data as of March 12, 2013