4004, 4004M CapSure |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Feb-89 | Serial Number Prefix | PS or LAV | |
| Registered US Implants | 72,600 | Type and/or Fixation | Transvenous, Vent., Tines | |
| Estimated Active US Implants | 5,800 | Polarity | Bipolar | |
| Steroid | Yes | |||
| Advisories | 1 | 1993 Lead Survival Below Expectations | ||
| Ventricular Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 1,640 | |||||||||
| Cumulative Months of Follow-Up | 71,653 | |||||||||
| Number of Leads Active in Study | 4 | |||||||||
| Qualifying Complications | 277 Total | |||||||||
| Conductor Fracture | 7 | |||||||||
| Electrical Abandonment | 1 | |||||||||
| Extra Cardiac Stimulation | 2 | |||||||||
| Failure to Capture | 131 | |||||||||
| Failure to Sense | 62 | |||||||||
| Impedance Out of Range | 32 | |||||||||
| Insulation (ESC) | 4 | |||||||||
| Insulation (MIO) | 4 | |||||||||
| Insulation (not further defined) | 7 | |||||||||
| Medical Judgment | 1 | |||||||||
| Oversensing | 25 | |||||||||
| Unspecified Clinical Failure | 1 | |||||||||
