BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY VR

    MDR report key: 4153566 · Received October 8, 2014

    Report

    Report Number
    2938836-2014-16341
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    August 11, 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
    CA, US
    Reporter Occupation
    NURSE

    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 A GRADUAL INCREASE IN HIGH VOLTAGE LEAD IMPEDANCE IN THE SVC TO CAN VECTOR WAS OBSERVED. THE PATIENT RECEIVED A VIBRATORY ALERT AND A MERLIN.NET TRANSMISSION. THE PATIENT NOTIFIER WAS PROGRAMMED OFF. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631477 FORTIFY VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD1231-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR