4068 CapSureFix |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Mar-96 | Serial Number Prefix | LCE | |
| Registered US Implants | 124,800 | Type and/or Fixation | Transvenous, V or A, Screw-in | |
| Estimated Active US Implants | 43,900 | Polarity | Bipolar | |
| Advisories | None | Steroid | Yes | |
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 2,411 | |||||||||
| Cumulative Months of Follow-Up | 124,306 | |||||||||
| Number of Leads Active in Study | 552 | |||||||||
| Qualifying Complications | 60 Total | |||||||||
| Conductor Fracture | 2 | |||||||||
| Extra Cardiac Stimulation | 1 | |||||||||
| Failure to Capture | 19 | |||||||||
| Failure to Sense | 11 | |||||||||
| Impedance Out of Range | 6 | |||||||||
| Insulation (ESC) | 2 | |||||||||
| Insulation (not further defined) | 1 | |||||||||
| Lead Dislodgement | 8 | |||||||||
| Oversensing | 7 | |||||||||
| Unspecified Clinical Failure | 3 | |||||||||
| Ventricular Placement | ||||
|---|---|---|---|---|
| System Longevity Study Results | ||||
| Number of Leads Enrolled in Study | 1,799 | |||
| Cumulative Months of Follow-Up | 89,241 | |||
| Number of Leads Active in Study | 457 | |||
| Qualifying Complications | 38 Total | |||
| Conductor Fracture | 2 | |||
| Extra Cardiac Stimulation | 2 | |||
| Failure to Capture | 20 | |||
| Failure to Sense | 3 | |||
| Impedance Out of Range | 5 | |||
| Oversensing | 4 | |||
| Unspecified Clinical Failure | 2 | |||
