BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K ADVANTAGE IMPLANT

    MDR report key: 2821007 · Received October 26, 2012

    Report

    Report Number
    3006556115-2012-00479
    Event Type
    Injury
    Date Received
    October 26, 2012
    Date of Event
    October 5, 2012
    Report Date
    October 11, 2012
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT EXPERIENCED NAUSEA AND DIZZINESS 12 DAYS AFTER IMPLANT SURGERY. THE PT WENT TO THE EMERGENCY ROOM AND RECEIVED A CT SCAN AND IV (TYPE UNK). THE PT WAS PLACED ON CORTISONE AND THE DOCTOR PRESCRIBED VESTIBULAR REHABILITATION. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K ADVANTAGE IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC CI-1500-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention