BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLARION

    MDR report key: 421969 · Received October 15, 2002

    Report

    Report Number
    2029203-2002-00276
    Event Type
    Death
    Date Received
    October 15, 2002
    Date of Event
    June 1, 2001
    Report Date
    October 11, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001, THE PATIENT INITIATED A PROCESS OF HEADACHE, MIDDLE OTITIS, FEVER, VOMITING, AND STIFFNESS OF THE NECK. PT WAS ADMITTED TO A HOSPITAL AND THEY PERFORMED A LUMBAR PUNCTURE WHICH CONFIRMED PNEUMOCOCCUS. THE PATIENT DIED A FEW DAYS LATER. THE FINAL DEATH DIAGNOSIS WAS MENINGITIS BY PNEUMOCOCCUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION AB-5100R NA

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Death| H