Model Number CD3357-40Q |
Device Problems
Premature Discharge of Battery (1057); Battery Problem (2885)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/16/2020 |
Event Type
Injury
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Manufacturer Narrative
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The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.The results/method and conclusion codes along with investigation results will be provided in the final report.
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Event Description
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Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted and replaced on (b)(6) 2020.The patient was in stable condition.
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Manufacturer Narrative
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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.
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Search Alerts/Recalls
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