BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONIC DEFIBRILLATOR

    MDR report key: 5124239 · Received October 1, 2015

    Report

    Report Number
    MW5056773
    Event Type
    Other
    Date Received
    October 1, 2015
    Date of Event
    January 1, 2014
    Report Date
    October 1, 2015
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    LWS
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Description of Event or Problem · 1

    CALLER REPORTED HER HUSBAND WAS INAPPROPRIATELY SHOCKED THREE TIMES CONSECUTIVELY IN 2014. HE WAS TAKEN TO THE HOSPITAL AND HAD THE LEAD WIRE DISCONNECTED. CALLER STATED HER HUSBAND HAD THE DEVICE IMPLANTED IN (B)(6)2010, HE HASN'T HAD ANY ISSUES WITH THE DEVICE UNTIL THE EVENT IN 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648212 MEDTRONIC DEFIBRILLATOR DEFIBRILLATOR LWS MEDTRONIC VASCULAR 6947

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR