BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 4140191 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05956
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    September 15, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MFR, 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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ERROR MESSAGE APPEARED WHEN INTERROGATING A DEVICE AND WOULD NOT ALLOW RETRIEVAL OF EPISODES. STORED ELECTROGRAMS WERE RECOVERED FROM A DEVICE IMAGE SENT TO TECHNICAL SERVICES AND THE ERROR WAS CLEARED AFTER UPDATED DEVICE CODE WAS RELOADED. THE DEVICE REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34263 CONFIRM IMPLANTABLE CARDIAC MONITOR MXC ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI DM2100

    Patients

    Seq Age Sex Outcome Treatment
    1