BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 2003127 · Received February 15, 2011

    Report

    Report Number
    3006556115-2011-00050
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 25, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT REPORTEDLY EXPERIENCED A SUDDEN LOSS OF SOUND. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING CHANGES WERE MADE. TESTING REVEALED LOSS OF LOCK BETWEEN THE EXTERNAL EQUIPMENT AND THE IMPLANTED DEVICE. THE PATIENT'S DEVICE WAS EXPLANTED.

    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 3 YR