BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC.

    MDR report key: 380538 · Received March 5, 2002

    Report

    Report Number
    MW1024280
    Event Type
    Injury
    Date Received
    March 5, 2002
    Date of Event
    November 21, 1999
    Report Date
    March 1, 2002
    Manufacturer
    MEDTRONIC INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT WITH IMPLANTABLE CARDIOVERTER DEFIBRILLATOR PLACED IN 1999. THE NEXT MONTH, THE PT BEGAN TO RECEIVE ICD SHOCKS. FURTHER EPISODES OCCURRED. DEVICE WAS INTERROGATED AND FOUND THERE WAS A SENSING DYSFUNCTION IN THE RECENTLY PLACED VENTRICULAR LEAD WHICH RESULTED IN APPROPRIATE ICD SHOCKS. VENTRICULAR LEAD EXPLANTED WITH NEW LEAD PLACED. DEVICE APPROPRIATELY FUNCTIONING POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. VENTRICULAR SENSING LEAD LWS MEDTRONIC INC. 694365 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization