BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3934649 · Received June 25, 2014

    Report

    Report Number
    3006556115-2014-00336
    Event Type
    Injury
    Date Received
    June 25, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT REPORTEDLY COULD NOT ACHIEVE LOCK WITH THE NEWLY IMPLANTED DEVICE AT INITIAL ACTIVATION. THE INTERNAL DEVICE APPEARS TO BE PROTRUDING. AN X-RAY REVEALED THE DEVICE IS FOLDED. REPOSITION SURGERY IS BEING CONSIDERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371977 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CL-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention