BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2151651 · Received June 30, 2011

    Report

    Report Number
    3006556115-2011-00320
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    January 21, 2011
    Report Date
    June 10, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED A LACK OF BENEFIT WITH THE DEVICE AND BECAME A NON-USER. THE PATIENT'S DEVICE WAS EXPLANTED. THERE ARE NO PLANS TO REIMPLANT THIS PATIENT.

    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 43 YR Required Intervention