BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONFIRM

    MDR report key: 4121487 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-07782
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 20, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC., CRM
    Product Code
    MXC
    PMA / PMN Number
    K081365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 A PATIENT WHO PRESENTED FOR ROUTINE FOLLOW-UP RECEIVED AN ERROR MESSAGE, BUT DID NOT REMEMBER WHAT THE ERROR MESSAGE SAID. DEVICE IMAGE ANALYZER TOOL SHOWED A COUPLE OF VALID SEGMENTS, BUT MANY MORE LISTED. DEVICE INFORMATION WAS SENT TO ENGINEERING FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32257 CONFIRM IMPLANTABLE CARDIAC MONITORY, MXC MXC ST. JUDE MEDICAL, INC., CRM DM2100

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR