BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUADRA ASSURA MP ICD

    MDR report key: 6156459 · Received December 8, 2016

    Report

    Report Number
    2938836-2016-14905
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Report Date
    November 7, 2016
    Manufacturer
    ST. JUDE MEDICAL, INC
    Product Code
    NIK
    PMA / PMN Number
    P030054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    THE DEVICE CHANGED TO BACKUP MODE. THE DEVICE FIRMWARE WAS RELOADED AND PARAMETERS AND PROGRAMMING WAS SUCCESSFULLY RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806355 QUADRA ASSURA MP ICD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR NIK ST. JUDE MEDICAL, INC CD3371-40QC 4790738

    Patients

    Seq Age Sex Outcome Treatment
    1