BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC SOLETRA

    MDR report key: 2061424 · Received April 7, 2011

    Report

    Report Number
    2061424
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 7, 2011
    Manufacturer
    MEDTRONIC
    Product Code
    MHY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD THE PULSE GENERATOR IMPLANTED. AFTER IMPLANTATION, THE DEVICE FAILED AND THIS RESULTED IN THE NEED FOR PLACEMENT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SOLETRA LEAD, STIMULATOR MHY MEDTRONIC 7426 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR