BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3960144 · Received June 23, 2014

    Report

    Report Number
    3006556115-2014-00306
    Event Type
    Malfunction
    Date Received
    June 23, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED POOR SOUND QUALITY AND INTERMITTENT LOCK, FOLLOWED BY LOSS OF LOCK. EXTERNAL EQUIPMENT WAS EXCHANGED, HOWEVER, THE ISSUE WAS NOT RESOLVED. REVISION SURGERY IS UNDER CONSIDERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364698 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR