BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 1327152 · Received February 25, 2009

    Report

    Report Number
    MW5010065
    Event Type
    Injury
    Date Received
    February 25, 2009
    Date of Event
    August 7, 2008
    Report Date
    January 30, 2009
    Manufacturer
    MEDTRONIC INC
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FOR ROUTINE TELEPHONE PACE-MAKER CHECK IN 2008, NO PACING SPIKES OR MAGNET RESPONSE. DEVICE INTERROGATED THE NEXT DAY, IN CENTER, NO PM FUNCTION. PER MEDTRONIC TECH SUPPORT. QUESTION SUDDEN BATTERY DEPLETION VS COMPONENT FAILURE. ADMITTED TO HOSPITAL ON THE SAME DAY. DEVICE REPLACED FOUR DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC KDR601 KAPPA DXY MEDTRONIC INC KDR 601

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Hospitalization| R