Model Number V173 |
Device Problem
Premature Discharge of Battery (1057)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/18/2021 |
Event Type
Injury
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited premature battery depletion.Subsequently, the patient underwent a revision procedure, and this product was explanted and replaced.This device has been returned and is in the process of device analysis.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Visual examination of the device header and case noted no anomalies.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
|
|
Event Description
|
It was reported that this cardiac resynchronization therapy pacemaker (crt-p) exhibited premature battery depletion.Subsequently, the patient underwent a revision procedure, and this product was explanted and replaced.This device has been returned and is in the process of device analysis.No additional adverse patient effects were reported.
|
|
Search Alerts/Recalls
|