BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3221605 · Received July 9, 2013

    Report

    Report Number
    3006556115-2013-00303
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 18, 2013
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED SOUND QUALITY ISSUES AND DECREASE IN PERFORMANCE. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING CHANGES WERE MADE; HOWEVER, THE ISSUE WAS NOT RESOLVED. REVISION SURGERY HAS BEEN SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312815 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention