BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2202250 · Received August 3, 2011

    Report

    Report Number
    3006556115-2011-00385
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    July 16, 2011
    Report Date
    July 16, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED TINNITUS AND DRAINAGE FROM THE IMPLANTED EAR. THE PT WAS TREATED WITH ANTIBIOTICS (TYPE UNK) ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO; ONCE, MORE INFO IS AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention