Model Number CD3357-40C |
Device Problems
Premature Discharge of Battery (1057); Difficult to Interrogate (1331)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/04/2019 |
Event Type
Injury
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Manufacturer Narrative
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The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device is included in the battery performance alert advisory issued by abbott on 28 august 2017.
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Event Description
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It was reported that the patient presented for a follow-up in clinic.The device could not be interrogated.The physician alleged that the device's battery depleted prematurely.The device was explanted and replaced.The patient was stable.
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Manufacturer Narrative
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Correction: please remove recall number as battery performance alert was not triggered.
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Manufacturer Narrative
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Premature battery depletion was confirmed by analysis.Bench testing on the device was performed, and no sources of high current were noted.The cause of the premature battery depletion was consistent with 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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