BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR

    MDR report key: 3943855 · Received July 18, 2014

    Report

    Report Number
    2938836-2014-13493
    Event Type
    Malfunction
    Date Received
    July 18, 2014
    Date of Event
    June 9, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A TRANSMISSION FOR BACK UP VVI VIA MERLIN.NET. UPON FURTHER INVESTIGATION, IT WAS NOTED THAT THE BACK UP VVI TRANSMISSION WAS INAPPROPRIATE. THE DEVICE WAS NOT FOUND IN BACK UP VVI. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421810 FORTIFY DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR