BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 3920548 · Received July 8, 2014

    Report

    Report Number
    2017865-2014-14147
    Event Type
    Malfunction
    Date Received
    July 8, 2014
    Date of Event
    May 27, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING FOLLOW-UP, THE IMPLANTABLE CARDIAC MONITOR EXHIBITED BACKUP OPERATION. AFTER A DEVICE FIRMWARE DOWNLOAD, NORMAL FUNCTION RESUMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395699 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, INC., CRMD DM2100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR