4504, 4504M CapSure |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Mar-90 | Serial Number Prefix | QM or LBA | |
| Registered US Implants | 15,400 | Type and/or Fixation | Transvenous, Atrial-J, Tines | |
| Estimated Active US Implants | 1,700 | Polarity | Bipolar | |
| Steroid | Yes | |||
| Advisories | 1 | 1996 Lead Survival Below Expectations | ||
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 368 | |||||||||
| Cumulative Months of Follow-Up | 19,879 | |||||||||
| Number of Leads Active in Study | 1 | |||||||||
| Qualifying Complications | 48 Total | |||||||||
| Electrical Abandonment | 3 | |||||||||
| Extra Cardiac Stimulation | 1 | |||||||||
| Failure to Capture | 14 | |||||||||
| Failure to Sense | 16 | |||||||||
| Impedance Out of Range | 9 | |||||||||
| Insulation (MIO) | 1 | |||||||||
| Lead Dislodgement | 1 | |||||||||
| Oversensing | 3 | |||||||||
