Model Number L331 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
|
Patient Problems
No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/23/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
This device has been returned for analysis.This report will be updated upon completion of analysis.
|
|
Event Description
|
It was reported that this pacemaker was interrogated prior to implant and was found to be operating in safety mode.The device was not implanted and was returned for analysis.There was no patient involvement.
|
|
Manufacturer Narrative
|
Upon receipt at our post market quality assurance laboratory, the clinically observed error message was confirmed.It was confirmed that the device underwent a reset due to a temporary, intermittent loss of battery power which resulted in the observed error message.Following the reset, the device reverted to a safety mode.The exact root cause of the loss of battery power could not be determined as the device operated normally throughout laboratory testing.This device has been returned for analysis.This report will be updated upon completion of analysis.
|
|
Event Description
|
It was reported that this pacemaker was interrogated prior to implant and was found to be operating in safety mode.The device was not implanted and was returned for analysis.There was no patient involvement.
|
|
Search Alerts/Recalls
|