BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE BIONICS LLC

    MDR report key: 3931213 · Received June 25, 2014

    Report

    Report Number
    3931213
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 23, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ADVANCED BIONICS
    Product Code
    MCM
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RT COCHLEAR IMPLANT FAILED. PATIENT COMPLAINED THAT IT WAS NOT WORKING. PATIENT HAD SURGERY TO REMOVE AND REPLACED IT FOR A NEW IMPLANT. WHEN REMOVED THE DEVICE APPEARED TO BE GROSSLY INTACT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371033 ADVANCE BIONICS LLC IMPLANT, COCHLEAR MCM ADVANCED BIONICS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR