BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2023812 · Received March 8, 2011

    Report

    Report Number
    3006556115-2011-00090
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 16, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REPORTEDLY EXPERIENCING SORENESS AND PAIN WHEN USING THE DEVICE. THE PT WAS PRESCRIBED WITH STEROIDS AND ANTIBIOTICS (TYPE UNK). THE PATIENT'S SYMPTOMS DID NOT IMPROVE AFTER USE OF PRESCRIBED TREATMENT. TESTING SHOWED THAT THE DEVICE IS FUNCTIONING. THE PT IS CURRENTLY BEING MONITORED.

    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 72 YR Required Intervention