5024, 5024M CapSure SP |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Mar-90 | Serial Number Prefix | SY or LAT | |
| Registered US Implants | 201,500 | Type and/or Fixation | Transvenous, Vent., Tines | |
| Estimated Active US Implants | 56,200 | Polarity | Bipolar | |
| Advisories | None | Steroid | Yes | |
| Ventricular Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 8,140 | |||||||||
| Cumulative Months of Follow-Up | 431,840 | |||||||||
| Number of Leads Active in Study | 594 | |||||||||
| Qualifying Complications | 48 Total | |||||||||
| Conductor Fracture | 3 | |||||||||
| Extra Cardiac Stimulation | 2 | |||||||||
| Failure to Capture | 25 | |||||||||
| Failure to Sense | 2 | |||||||||
| Impedance Out of Range | 3 | |||||||||
| Insulation (ESC) | 1 | |||||||||
| Insulation (not further defined) | 5 | |||||||||
| Lead Dislodgement | 5 | |||||||||
| Oversensing | 1 | |||||||||
| Unspecified Clinical Failure | 1 | |||||||||
