BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 3884675 · Received June 19, 2014

    Report

    Report Number
    2938836-2014-12182
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING TWO INAPPROPRIATE SHOCKS. REVIEW OF THE EPISODES FOUND POST-SENSED T-WAVE OVERSENSING. PROGRAMMING CHANGES WERE MADE AND THE PATIENT WAS PLACED ON BETA BLOCKERS. THE PATIENT CONDITION WAS STABLE AFTER THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361551 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention