BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 4132709 · Received September 29, 2014

    Report

    Report Number
    3006556115-2014-00448
    Event Type
    Injury
    Date Received
    September 29, 2014
    Date of Event
    September 8, 2014
    Report Date
    September 8, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT HAS REPORTEDLY EXPERIENCED ONGOING INTERMITTENT LOCK ISSUES WITH USE OF THE DEVICE. PROGRAMMING CHANGES WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. DEVICE REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604949 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention