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QUADRA ASSURA MP ICD Adverse Event — Malfunction (MDR 2938836-2020-02851)

QUADRA ASSURA MP ICD Adverse Event — Malfunction (MDR 2938836-2020-02851) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: QUADRA ASSURA MP ICD; Generic name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; Manufacturer: ABBOTT.

DeviceQUADRA ASSURA MP ICD
Generic nameIMPLANTABLE CARDIOVERTER DEFIBRILLATOR
ManufacturerABBOTT
Report number2938836-2020-02851
Event typeMalfunction
Product problemY
Date received2020-04-28
Report sourceCOMPANY REPRESENTATIVE, FOREIG
NarrativeTHE 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.
SourceopenFDA MAUDE (device adverse events)

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