BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 2992940 · Received March 1, 2013

    Report

    Report Number
    3006556115-2013-00077
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    February 17, 2013
    Report Date
    February 17, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NO INFORMATION

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED ONGOING INTERMITTENCIES FOLLOWED BY LOSS OF LOCK BETWEEN THE INTERNAL DEVICE AND THE EXTERNAL EQUIPMENT. EXTERNAL EQUIPMENT WAS EXCHANGED; HOWEVER, THE ISSUE WAS NOT RESOLVE. THE EXPLANT SURGERY WILL BE SCHEDULED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89375 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR