BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIRES 90K

    MDR report key: 1080635 · Received July 22, 2008

    Report

    Report Number
    3006556115-2008-00357
    Event Type
    Malfunction
    Date Received
    July 22, 2008
    Date of Event
    June 24, 2008
    Report Date
    June 24, 2008
    Manufacturer
    ADVANCED BIONICS LLC
    Product Code
    MCM
    PMA / PMN Number
    P960058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT REPORTEDLY EXPERIENCED A DECREASE IN SOUND PERFORMANCE WITH HER INTERNAL DEVICE. IN ADDITION, IT WAS ALSO REPORTED THAT THE PT EXPERIENCED PAIN AND DISCOMFORT WITH HER DEVICE. THE PT'S DEVICE WAS EXPLANTED. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFO. WHEN MORE INFO BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HIRES 90K COCHLEAR IMPLANT MCM ADVANCED BIONICS LLC CI-1400-01 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention