BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLARION

    MDR report key: 1791580 · Received July 28, 2010

    Report

    Report Number
    3006556115-2010-00359
    Event Type
    Malfunction
    Date Received
    July 28, 2010
    Date of Event
    July 7, 2010
    Report Date
    July 7, 2010
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT REPORTEDLY EXPERIENCED INTERMITTENCIES. EXTERNAL EQUIPMENT WAS EXCHANGED AND PROGRAMMING ADJUSTMENTS WERE ATTEMPTED; HOWEVER, THIS DID NOT RESOLVE THE ISSUE. EXPLANT OF INTERNAL DEVICE IS BEING CONSIDERED. ADVANCED BIONICS IS INVESTIGATING THIS REPORT AND WILL PROVIDE A SUPPLEMENTAL REPORT WHEN MORE INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLARION COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC AB-5100H-11 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR