BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3811044 · Received March 24, 2014

    Report

    Report Number
    3006556115-2014-00115
    Event Type
    Injury
    Date Received
    March 24, 2014
    Date of Event
    February 17, 2014
    Report Date
    March 3, 2014
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED POST IMPLANT TINNITUS, AND OVERLY LOUD STIMULATION. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, IT DID NOT RESOLVE THE ISSUE. THE PATIENT'S DEVICE WAS EXPLANTED. THERE ARE NO PLANS FOR DEVICE RE-IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173611 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-02H NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention