Model Number CD2357-40Q |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/22/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
The results/method and conclusion codes along with investigation results will be provided in the final report.
|
|
Event Description
|
It was reported that the device exhibited premature battery depletion and had reached the elective replacement indicator.Additionally, following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.The patient was in stable condition.
|
|
Manufacturer Narrative
|
Premature battery depletion was confirmed by analysis.No sources of high current were noted.The cause of the premature battery depletion was consistent with lithium (li) cluster formation.From these analyses, in the absence of high current draw, it is probable that the premature battery depletion was caused by a lithium cluster induced short circuit.Li clusters are a known depletion mechanism for these advisory products that has been investigated and associated with a field action in october 2016.
|
|
Search Alerts/Recalls
|