5076 CapSureFix Novus |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Aug-00 | Serial Number Prefix | PJN | |
| Registered US Implants | 1,025,600 | Type and/or Fixation | Transvenous, V or A, Screw-in | |
| Estimated Active US Implants | 723,800 | Polarity | Bipolar | |
| Advisories | None | Steroid | Yes | |
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 2,678 | |||||||||
| Cumulative Months of Follow-Up | 104,689 | |||||||||
| Number of Leads Active in Study | 1,207 | |||||||||
| Qualifying Complications | 16 Total | |||||||||
| Cardiac Perforation | 1 | |||||||||
| Conductor Fracture | 1 | |||||||||
| Extra Cardiac Stimulation | 2 | |||||||||
| Failure to Capture | 4 | |||||||||
| 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 | 1,521 | |||
| Cumulative Months of Follow-Up | 55,080 | |||
| Number of Leads Active in Study | 556 | |||
| 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 | |||
