BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2243611 · Received July 27, 2011

    Report

    Report Number
    3006556115-2011-00373
    Event Type
    Malfunction
    Date Received
    July 27, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING SOUND QUALITY ISSUES AND PAIN DURING USE OF HER COCHLEAR IMPLANT. EXTERNAL EQUIPMENT WAS EXCHANGED AND EXTENSIVE PROGRAMMING CHANGES WERE MADE; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. THE CENTER WILL PURSUE DEVICE REVISION SURGERY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR