BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS II VR

    MDR report key: 3910986 · Received July 2, 2014

    Report

    Report Number
    2938836-2014-13046
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    May 15, 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
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE REACHED THE MAXIMUM CHARGE TIME. THE DEVICE WAS ELECTIVELY EXPLANTED AND REPLACED DUE TO NORMAL BATTERY DEPLETION. THE PATIENT WAS IN GOOD MEDICAL CONDITION FOLLOWING THE EVENT. THE DEVICE WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386495 ATLAS II VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-168 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention