BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONFIRM

    MDR report key: 3925527 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08650
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    March 28, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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 REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONFIRM MONITOR DEVICE EXHIBITED BACKUP VVI OPERATION AND REPORTED MANY WRONG EPISODES OF INTERFERENCES. THE PATIENT EXPERIENCED SYNCOPE. THE CONFIRM DEVICE WAS EXPLANTED AND THE PHYSICIAN DECIDED TO IMPLANT A PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38195 CONFIRM IMPLANTABLE CARDIAC MONITOR, MXC MXC ST. JUDE MEDICAL, INC., CRMD DM2100

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention