BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 3140960 · Received May 24, 2013

    Report

    Report Number
    3006556115-2013-00247
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 21, 2013
    Report Date
    May 21, 2013
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS HOSPITALIZED IN THE ICU WITH THE DIAGNOSIS OF LABYRINTH INFECTION WITH MENINGITIS SYMPTOMS. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231643 NI COCHLEAR IMPLANT MCM ADVANCED BIONICS, LLC NI NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R