BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2103682 · Received May 20, 2011

    Report

    Report Number
    3006556115-2011-00273
    Event Type
    Injury
    Date Received
    May 20, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 16, 2011
    Manufacturer
    ADVANCED BIONICS, LLC.
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT WAS HOSPITALIZED FOR AND DIAGNOSED WITH H-FLU BACTERIAL MENINGITIS ON (B)(6) 2011. THE PT WAS PRESCRIBED ANTIBIOTICS (TYPE UNK). THE PT CONTINUES TO BE MONITORED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING ADD'L INFO AND WILL SUBMIT A SUPPLEMENTAL REPORT ONCE NEW INFO IS OBTAINED.

    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 78 YR Hospitalization| R