BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATLASS II VR

    MDR report key: 4172393 · Received January 13, 2014

    Report

    Report Number
    2938836-2014-01820
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    August 9, 2011
    Manufacturer
    ST. JUDE MEDICAL INC., CRMD
    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 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 ASYMPTOMATIC PATIENT PRESENTED IN CLINIC DURING FOLLOW UP WITH A DEVICE THAT WAS POST SENSED T WAVE OVERSENSING ON THE VENTRICULAR LEAD. THE PATIENT DID NOT RECEIVE THERAPY. DEVICE REPROGRAMMING AND INDUCTION TESTING WERE DISCUSSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27588 ATLASS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL INC., CRMD V-168

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR