BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1083066 · Received March 11, 2008

    Report

    Report Number
    3006556115-2008-00129
    Event Type
    Malfunction
    Date Received
    March 11, 2008
    Date of Event
    February 13, 2008
    Report Date
    February 13, 2008
    Manufacturer
    ADVANCED BIONICS, LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    AUDIOLOGIST

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED OVERLY LOUD SENSATIONS AND INTERMITTENCIES. REPROGRAMMING WAS PERFORMED BUT THE PROBLEM WAS NOT RESOLVED. AN EXCHANGE OF THE DEVICES EXTERNAL EQUIPMENT ALSO DID NOT RESOLVE THE PROBLEM. THE PATIENT ALSO REPORTS EPISODES OF TINNITUS SINCE HER REPROGRAMMING. A REVISION SURGERY WILL BE SCHEDULED TO RESOLVE THE ISSUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1