BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 1061434 · Received June 17, 2008

    Report

    Report Number
    3006556115-2008-00318
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    June 6, 2008
    Report Date
    May 20, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE IMPLANT SURGEON EXPLANTED THE PT'S DEVICE ON THE LEFT IMPLANT SIDE. AS A PRECAUTIONARY MEASURE, THE IMPLANT SURGEON EXPLANTED THE PT'S RIGHT DEVICE. THE PT REPORTED NO COMPLAINTS WITH THIS IMPLANT. TESTING OF THE DEVICE SHOWED THAT IT WAS FUNCTIONAL. THE PT WAS IMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    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