BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1882679 · Received October 18, 2010

    Report

    Report Number
    3006556115-2010-00503
    Event Type
    Malfunction
    Date Received
    October 18, 2010
    Date of Event
    September 27, 2010
    Report Date
    September 27, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED SUDDEN LOSS OF SOUND BETWEEN EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. THE EXTERNAL EQUIPMENT WAS EXCHANGED. THE ISSUE WAS NOT RESOLVED. REVISION SURGERY WILL BE SCHEDULED.

    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 58 YR