BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1232691 · Received November 14, 2008

    Report

    Report Number
    3006556115-2008-00598
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 24, 2008
    Report Date
    October 24, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED HEADACHES AND PAIN AROUND THE IMPLANT SITE. TESTING OF THE DEVICE SHOWED THAT THE DEVICE IS FUNCTIONING. THE PATIENT HAS SHINGLES WITH OUTBREAKS ON HER FACE ON THE SAME SIDE OF HER IMPLANT. THE PATIENT WAS PRESCRIBED ANTIBIOTICS (ACYCLOVIR) DAILY FOR 1 MONTH. SURGERY TO EXPLANT THE PATIENT'S DEVICE IS UNDER CONSIDERATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR