BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K IMPLANT

    MDR report key: 3971293 · Received June 30, 2014

    Report

    Report Number
    3006556115-2014-00338
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY CONTRACTED MENINGITIS. THE SURGEON REPORTED THAT THE PT'S MENINGITIS IS NOT RELATED TO THE PT'S IMPLANTED DEVICE. ADVANCED BIONICS IS IN THE PROCESS OF COLLECTING THE REQUIRED CLINICAL INFO NECESSARY TO DETERMINE THE PATHOLOGY OF THE REPORTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378793 HIRES 90K IMPLANT COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1