BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIRES 90K

    MDR report key: 2023808 · Received March 7, 2011

    Report

    Report Number
    3006556115-2011-00113
    Event Type
    Injury
    Date Received
    March 7, 2011
    Date of Event
    September 1, 2009
    Report Date
    March 3, 2011
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PT HAD A REPORTED CASE OF MENINGITIS IN (B)(6) 2009. 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 7 YR Required Intervention