BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCED BIONICS A

    MDR report key: 1153744 · Received September 8, 2008

    Report

    Report Number
    1153744
    Event Type
    Injury
    Date Received
    September 8, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 5, 2008
    Manufacturer
    ADVANCED BIOONICS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR SURGERY TO REMOVE A FAILED RIGHT COCHLEAR IMPLANT. A NEW COCHLEAR IMPLANT WAS PLACED AT THE TIME OF THE SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANCED BIONICS A COCHLEAR IMPLANT MCM ADVANCED BIOONICS G0700

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention