BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1141633 · Received August 28, 2008

    Report

    Report Number
    MW5008115
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 28, 2008
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS PT HAD A MEDTRONIC ICD IMPLANTED IN LATE 2006. THIS IS A MODEL NUMBER D154AWG VIRTUOSO DR. THIS PT HAD NEVER RECEIVED SHOCKS FROM HIS DEFIBRILLATOR, AND THE VOLTAGE OUTPUTS HAD CHRONICALLY BEEN SET TO 2 VOLTS AT 0.5MS. IN 2008, THE DEVICE REACHED ITS ELECTIVE REPLACEMENT INDICATOR, EVEN THOUGH IT HAD BEEN IMPLANTED ONLY 19 MONTHS. THIS PT IS GOING TO REQUIRE ANOTHER SURGICAL PROCEDURE TO REPLACE THIS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ICD LWS MEDTRONIC INC. D154AWG VIRTUOSO DR

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Disability