BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VIRTUOSO DR

    MDR report key: 2771341 · Received September 25, 2012

    Report

    Report Number
    2771341
    Event Type
    Malfunction
    Date Received
    September 25, 2012
    Date of Event
    July 5, 2012
    Report Date
    September 20, 2012
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH HISTORY OF TRANSPOSITION OF THE GREAT VESSELS STATUS POST "SENNING" AS AN INFANT WHO SUBSEQUENTLY DEVELOPED SINUS NODE DYSFUNCTION LEADING TO A PACEMAKER AND THEREAFTER SUSTAINED V-TACH IN THE SETTING OF POOR RV FUNCTION LEADING TO ICD IMPLANTATION. HIS GENERATOR IS NOW AT ERI AND HE PRESENTS FOR GENERATOR CHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VIRTUOSO DR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC. D154AWG *
    2 SPRINT FIDELIS LEAD, IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC. 6931 *

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR