BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2971115 · Received February 1, 2013

    Report

    Report Number
    3006556115-2013-00019
    Event Type
    Malfunction
    Date Received
    February 1, 2013
    Date of Event
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED INTERMITTENCY FOLLOWED BY LOSS OF LOCK BETWEEN THE EXTERNAL EQUIPMENT AND THE COCHLEAR IMPLANT. PROGRAMMING CHANGES WERE MADE, AND EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THE ISSUE WAS NOT RESOLVED. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    45290 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR