BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLARION

    MDR report key: 406151 · Received July 23, 2002

    Report

    Report Number
    2029203-2002-00166
    Event Type
    Death
    Date Received
    July 23, 2002
    Report Date
    July 23, 2002
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 2001, THE SURGEON CONTACTED CO'S DISTRIBUTOR TO INFORM MFR OF A PT WHO HAD DIED DUE TO MENINGITIS. THE SURGEON'S LETTER STATED THAT THE PT DEVELOPED "ENCEPHALITIS" AND DIED ONE WEEK LATER. THE HEAD OF THE IMPLANT CENTER ENT DIVISION, WHO IS ALSO THE IMPLANT SURGEON, INFORMED THE COMPANY THAT THE PT'S IMPLANT HAD BEEN WORKING PROPERLY PRIOR TO THE EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Death