BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS DR

    MDR report key: 3890523 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-04488
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    December 9, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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 PT PRESENTED IN THE EMERGENCY ROOM DUE TO MULTIPLE SHOCKS. UPON INTERROGATION THE DEVICE INDICATED THAT IT HAD EXPERIENCED A DEVICE RESET DUE TO MULTIPLE PARITY ERRORS. THE DEVICE IMAGE WOULD NOT COMPLETE AND THE REAL TIME CLOCK WAS FROZEN. DEVICE WAS PROGRAMMED. THE PT WAS PLANNED TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31339 ATLAS DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, LWS LWS ST. JUDE MEDICAL INC., CARDIAC RHYTHM MANAGEMENT D V-242

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR