BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2193481 · Received July 29, 2011

    Report

    Report Number
    3006556115-2011-00375
    Event Type
    Malfunction
    Date Received
    July 29, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT HAS REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. TESTING SHOWED THAT THE DEVICE IS NOT FUNCTIONING NORMALLY. 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 27 YR