4058, 4058M Screw-In |
Product Characteristics | |||
|---|---|---|---|---|
| US Market Release | Jan-89 | Serial Number Prefix | ZY or LAW | |
| Registered US Implants | 101,900 | Type and/or Fixation | Transvenous, V or A, Screw-in | |
| Estimated Active US Implants | 20,800 | Polarity | Bipolar | |
| Advisories | None | Steroid | No | |
| Atrial Placement | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| System Longevity Study Results |
|
|||||||||
| Number of Leads Enrolled in Study | 2,364 | |||||||||
| Cumulative Months of Follow-Up | 131,441 | |||||||||
| Number of Leads Active in Study | 44 | |||||||||
| Qualifying Complications | 33 Total | |||||||||
| Extra Cardiac Stimulation | 1 | |||||||||
| Failure to Capture | 15 | |||||||||
| Failure to Sense | 7 | |||||||||
| Impedance Out of Range | 5 | |||||||||
| Insulation (not further defined) | 1 | |||||||||
| Lead Dislodgement | 3 | |||||||||
| Oversensing | 1 | |||||||||
| Ventricular Placement | ||||
|---|---|---|---|---|
| System Longevity Study Results | ||||
| Number of Leads Enrolled in Study | 1,690 | |||
| Cumulative Months of Follow-Up | 77,493 | |||
| Number of Leads Active in Study | 49 | |||
| Qualifying Complications | 53 Total | |||
| Conductor Fracture | 5 | |||
| Extra Cardiac Stimulation | 3 | |||
| Failure to Capture | 22 | |||
| Failure to Sense | 10 | |||
| Impedance Out of Range | 7 | |||
| Insulation (not further defined) | 4 | |||
| Lead Dislodgement | 1 | |||
| Oversensing | 1 | |||
