BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3853280 · Received April 4, 2014

    Report

    Report Number
    3006556115-2014-00135
    Event Type
    Malfunction
    Date Received
    April 4, 2014
    Date of Event
    March 14, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED SOUND QUALITY ISSUES. EXTERNAL EQUIPMENT WAS EXCHANGED WITHOUT RESOLVE. TESTING OF THE DEVICE REVEALED ABNORMAL FUNCTION. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS COCHLEAR IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205273 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR