5068 CapSureFix |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Jan-97 | Serial Number Prefix | LDJ | |
| Registered US Implants | 103,100 | Type and/or Fixation | Transvenous, V or A, Screw-in | |
| Estimated Active US Implants | 40,600 | Polarity | Bipolar | |
| Advisories | None | Steroid | Yes | |
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 968 | |||||||||
| Cumulative Months of Follow-Up | 32,929 | |||||||||
| Number of Leads Active in Study | 65 | |||||||||
| Qualifying Complications | 6 Total | |||||||||
| Failure to Capture | 2 | |||||||||
| Impedance Out of Range | 2 | |||||||||
| Lead Dislodgement | 1 | |||||||||
| Oversensing | 1 | |||||||||
| Ventricular Placement | ||
|---|---|---|
| System Longevity Study Results | ||
| Number of Leads Enrolled in Study | 1,359 | |
| Cumulative Months of Follow-Up | 37,307 | |
| Number of Leads Active in Study | 119 | |
| Qualifying Complications | 6 Total | |
| Conductor Fracture | 1 | |
| Failure to Capture | 3 | |
| Insulation (not further defined) | 1 | |
| Lead Dislodgement | 1 | |
