BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1812820 · Received July 6, 2010

    Report

    Report Number
    3006556115-2010-00335
    Event Type
    Malfunction
    Date Received
    July 6, 2010
    Date of Event
    January 15, 2005
    Report Date
    June 29, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ADVANCED BIONICS CONSIDERS THE INVESTIGATION INTO THIS REPORTABLE EVENT AS CLOSED. DUE TO LIMITED INFORMATION AVAILABLE ON THE RECEIVED MED WATCH FORM, THE IDENTITY OF THE PATIENT REMAINS UNKNOWN. THIS IS THE FINAL REPORT.

    Description of Event or Problem · 1

    THE COMPANY WAS INFORMED THAT THE PATIENT EXPERIENCED POOR PERFORMANCE, SOUND QUALITY ISSUES AND OVERLY LOUD SENSATIONS. THE PATIENT'S DEVICE WAS EXPLANTED. THE PATIENT WAS REIMPLANTED WITH ANOTHER ADVANCED BIONICS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1