BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIR 90K

    MDR report key: 805768 · Received January 17, 2007

    Report

    Report Number
    2029203-2007-00034
    Event Type
    Injury
    Date Received
    January 17, 2007
    Date of Event
    January 7, 2007
    Report Date
    January 17, 2007
    Manufacturer
    ADVANCED BIONICS CORP.
    Product Code
    MCM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS IS IN THE PROCESS OF COLLECTING THE REQUIRED CLINICAL INFORMATION NECESSARY TO DETERMINE THE PATHOLOGY OF THE REPORTED INFECTION.

    Description of Event or Problem · 1

    THE COMPANY WAS NOTIFIED THAT THE PATIENT REPORTEDLY HAD BEEN HOSPITALIZED FOR TREATMENT OF BACTERIAL MENINGITIS IN 2007. IT WAS REPORTED THAT THE PATIENT IS IN SERIOUS CONDITION. A DECISION WAS MADE TO EXPLANT THE DEVICE BY THE PATIENT'S MEDICAL TEAM. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT REMAINS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIR 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS CORP. CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Hospitalization| L| R