5524, 5524M CapSure SP |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Mar-90 | Serial Number Prefix | XV or LAV | |
| Registered US Implants | 60,600 | Type and/or Fixation | Transvenous, Atrial-J, Tines | |
| Estimated Active US Implants | 21,000 | Polarity | Bipolar | |
| Advisories | None | Steroid | Yes | |
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 4,445 | |||||||||
| Cumulative Months of Follow-Up | 241,326 | |||||||||
| Number of Leads Active in Study | 482 | |||||||||
| Qualifying Complications | 38 Total | |||||||||
| Conductor Fracture | 1 | |||||||||
| Failure to Capture | 22 | |||||||||
| Failure to Sense | 4 | |||||||||
| Impedance Out of Range | 1 | |||||||||
| Insulation (not further defined) | 2 | |||||||||
| Lead Dislodgement | 4 | |||||||||
| Oversensing | 4 | |||||||||
