BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 645002 · Received October 14, 2005

    Report

    Report Number
    645002
    Event Type
    Malfunction
    Date Received
    October 14, 2005
    Date of Event
    August 29, 2005
    Report Date
    October 14, 2005
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    REPLACEMENT OF COCHLEAR DEVICE AFTER FAILURE CONFIRMED BY MANUFACTURER, ADVANCED BIONICS CORPORATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION 6798 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *