Model Number 408719 |
Device Problems
High impedance (1291); Ambient Noise Problem (2877)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/08/2024 |
Event Type
malfunction
|
Event Description
|
Lead shows out of range impedance measurements (greater than 3000 ohms) and noise on the lv channel.Lead remains implanted.No adverse patient events were reported.Should additional information be received, this file will be updated.
|
|
Manufacturer Narrative
|
The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
|
|
Manufacturer Narrative
|
Lead was explanted (b)(6)2024.The device is currently not available for analysis.No conclusion can be drawn at this time.No additional information is available at the moment.The file is closed.The investigation will be re-opened should additional data become available.
|
|
Search Alerts/Recalls
|