BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION IMPLANT

    MDR report key: 2850693 · Received November 20, 2012

    Report

    Report Number
    3006556115-2012-00532
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 30, 2012
    Report Date
    November 5, 2012
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT WAS EXPERIENCING HEADACHES, DIZZINESS AND PAIN AT THE IMPLANT SITE. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER COCHLEAR DEVICE. THE PATIENT HAS NOT HAD ANY REPORTS OF HEADACHES OR DIZZINESS SINCE BEING REIMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Required Intervention