BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT DR

    MDR report key: 3890214 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04466
    Event Type
    Injury
    Date Received
    January 13, 2014
    Date of Event
    October 27, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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 AN ALERT FOR DEVICE SOFTWARE UPGRADE IS REQUIRED WAS PRESENTED UPON INTERROGATING THE DEVICE DURING NORMAL FOLLOW-UP. DEVICE FIRMWARE UPGRADE PROCEDURE WAS FOLLOWED, BUT DURING THE UPGRADE, THE PROGRAMMING HEAD MOVED AND THE DEVICE REMAINED IN THE BACKUP STATE. THE DEVICE WAS RESTORED SUCCESSFULLY WITH A FIRMWARE DOWNLOAD. NOMINALS WERE RESTORED, AND THE DEVICE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33429 CURRENT DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CRMD 2107-36

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR