BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3830702 · Received May 5, 2014

    Report

    Report Number
    3006556115-2014-00202
    Event Type
    Injury
    Date Received
    May 5, 2014
    Report Date
    April 14, 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 WAS REPORTEDLY EXPERIENCING POOR PERFORMANCE WITH THE DEVICE. THE PT HAS DECLINED EXCHANGING OF EQUIPMENT AND WOULD LIKE TO PROCEED WITH REVISION SURGERY. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. ONCE MORE INFO BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267340 HIRES 90K IMPLANT COHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention