BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 4190083 · Received January 11, 2014

    Report

    Report Number
    2017865-2014-02258
    Event Type
    Malfunction
    Date Received
    January 11, 2014
    Date of Event
    May 17, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE CARDIAC MONITOR DEVICE EXHIBITED BACKUP VVI OPERATION. IT WAS CLINICALLY RESOLVED BY A SUCCESSFUL SOFTWARE DOWNLOAD. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21546 CONFIRM IMPLANTABLE CARDIAC MONITOR, MXC MXC ST. JUDE MEDICAL, INC., CRMD DM2100

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR