BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2011584 · Received March 1, 2011

    Report

    Report Number
    3006556115-2011-00089
    Event Type
    Injury
    Date Received
    March 1, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 8, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING PAIN AND TENDERNESS AROUND THE IMPLANT SITE WITH AND WITHOUT DEVICE USE. THE PT WAS PRESCRIBED WITH LYRICA 50MG.

    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 54 YR Required Intervention