BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLARION

    MDR report key: 2062640 · Received April 8, 2011

    Report

    Report Number
    3006556115-2011-00155
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    January 10, 2006
    Report Date
    March 21, 2011
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS EVENT AS CLOSED. DUE DILIGENCE IN ATTEMPTING TO FOLLOW UP WITH THE PATIENT WAS UNSUCCESSFUL. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THE PATIENT REPORTED EXPERIENCING SOME INTERMITTENT SHARP SHOOTING PAINS AND DIZZINESS. DEVICE TESTING REVEALED THAT THE DEVICE WAS FUNCTIONING NORMALLY. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND STEROIDS (TYPES UNKNOWN) TO RULE OUT UNDERLYING LABYRINTHITIS. THE PATIENT WAS SCHEDULED FOR FOLLOW-UP IN TWO WEEKS. THE PATIENT DID NOT COMPLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention