BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORTICAL STIMULATOR WITH SSU AMPLIFIER

    MDR report key: 2211658 · Received August 5, 2011

    Report

    Report Number
    2126317-2011-00004
    Event Type
    Malfunction
    Date Received
    August 5, 2011
    Date of Event
    November 11, 2010
    Report Date
    August 4, 2011
    Manufacturer
    CAREFUSION 209
    Product Code
    ETN
    PMA / PMN Number
    K072964
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE CORTICAL STIMULATOR DEVICE APPEARED TO BE DELIVERING CURRENT TO THE CORRECT ELECTRODE PAIR WHEN IN FACT THERE WAS NO CURRENT BEING DELIVERED TO THE BRAIN TISSUE AS EVIDENCED BY NO EXPECTED RESPONSE FROM THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CORTICAL STIMULATOR WITH SSU AMPLIFIER CORTICAL STIMULATOR ETN CAREFUSION 209 NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other