BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLAS + VR

    MDR report key: 4091874 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-05159
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    January 24, 2012
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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 ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT OVERSENSING HAD BEEN OBSERVED ON THE DEVICE. ALL ELECTRICAL PARAMETERS ARE IN RANGE. NO LEAD DAMAGE APPEARED ON X-RAY. THE DEVICE WAS REPROGRAMMED. NO ADVERSE EVENTS WERE REPORTED. THE PATIENT MEDICAL CONDITION IS GOOD FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34133 ATLAS + VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD V-193

    Patients

    Seq Age Sex Outcome Treatment
    1