BEUDAMED
    FDA Adverse Event Death Summary report: N

    CLARION

    MDR report key: 881871 · Received July 18, 2007

    Report

    Report Number
    2029203-2007-00690
    Event Type
    Death
    Date Received
    July 18, 2007
    Date of Event
    July 14, 2007
    Report Date
    July 16, 2007
    Manufacturer
    ADVANCED BIONICS CORPORATION
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2007, THE PT EXPERIENCED FACIAL PALSY AND SOUND QUALITY ISSUES WITH HER DEVICE. THE CENTER PRESCRIBED STEROIDS FOR THE PATIENT AND SCHEDULED THE PT FOR FURTHER EVALUATION. THREE DAYS LATER, THE PT WAS ADMITTED TO THE HOSPITAL. THE PT PRESENTED AS LETHARGIC WITH SYMPTOMS OF HEADACHE AND NAUSEA. A LUMBAR PUNCTURE WAS ATTEMPTED, BUT COULD NOT BE COMPLETED. FIVE DAYS LATER, THE COMPANY WAS INFORMED THAT THE PT'S CONDITION HAD PROGRESSED TO MENINGITIS AND THAT THE PATIENT PASSED AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS CORPORATION AB-5100H-11

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Death| H| L| O| R