ST. JUDE MEDICAL, INC.(CRM-SYLMAR) FORTIFY ASSURA VR ICD, US; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
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Model Number CD1357-40Q |
Device Problem
Battery Problem (2885)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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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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Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.The patient was stable before, during, and after the procedure.
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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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