5076 CapSureFix Novus |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Aug-00 | Serial Number Prefix | PJN | |
| Registered US Implants | 1,098,200 | Type and/or Fixation | Transvenous, V or A, Screw-in | |
| Estimated Active US Implants | 772,600 | Polarity | Bipolar | |
| Advisories | None | Steroid | Yes | |
| Atrial Placement | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||||||
| Number of Leads Enrolled in Study | 2,691 | |||||||||||||
| Cumulative Months of Follow-Up | 112,052 | |||||||||||||
| Number of Leads Active in Study | 1,115 | |||||||||||||
| Qualifying Complications | 17 Total | |||||||||||||
| Cardiac Perforation | 1 | |||||||||||||
| Conductor Fracture | 1 | |||||||||||||
| Extra Cardiac Stimulation | 2 | |||||||||||||
| Failure to Capture | 5 | |||||||||||||
| Impedance Out of Range | 2 | |||||||||||||
| Insulation (not further defined) | 1 | |||||||||||||
| Lead Dislodgement | 4 | |||||||||||||
| Oversensing | 1 | |||||||||||||
| Ventricular Placement | ||||
|---|---|---|---|---|
| System Longevity Study Results | ||||
| Number of Leads Enrolled in Study | 1,525 | |||
| Cumulative Months of Follow-Up | 58,604 | |||
| Number of Leads Active in Study | 513 | |||
| Qualifying Complications | 9 Total | |||
| Cardiac Perforation | 1 | |||
| Conductor Fracture | 1 | |||
| Failure to Capture | 3 | |||
| Failure to Sense | 1 | |||
| Impedance Out of Range | 1 | |||
| Lead Dislodgement | 2 | |||
