BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2091135 · Received May 9, 2011

    Report

    Report Number
    3006556115-2011-00205
    Event Type
    Malfunction
    Date Received
    May 9, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    ADVANCED BIONICS, LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED INTERMITTENCY BETWEEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. PROGRAMMING CHANGES WERE MADE, AND EXTERNAL EQUIPMENT HAS BEEN EXCHANGED. HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PT LATER REPORTED LOSS OF LOCK. REVISION SURGERY HAS BEEN 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 89 YR