BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATLAS PLUS VR

    MDR report key: 3903600 · Received June 30, 2014

    Report

    Report Number
    2938836-2014-12820
    Event Type
    Injury
    Date Received
    June 30, 2014
    Date of Event
    April 29, 2005
    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
    TX, US
    Reporter Occupation
    OTHER

    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 PATIENT EXPERIENCED INAPPROPRIATE SHOCKS AT THE TIME OF IMPLANT IN 2005. NO FURTHER INFORMATION IS AVAILABLE WITH THE EXCEPTION THAT THE DEVICE FUNCTIONED NORMALLY FROM 2012 TO ELECTIVE EXPLANT IN 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379557 ATLAS PLUS VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD V-193 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR