BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 408451 · Received July 25, 2002

    Report

    Report Number
    MW1025721
    Event Type
    Malfunction
    Date Received
    July 25, 2002
    Date of Event
    July 11, 2002
    Report Date
    July 23, 2002
    Manufacturer
    MICRORECORDING SYSTEMS CONSULTANTS
    Product Code
    MUV
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DURING DEEP BRAIN STIMULATOR PLACEMENT (THERAPY FOR TREMOR) MICRO ELECTRODE BRAIN MAPPING WAS PERFORMED. RECORDINGS WITH FIRST ELECTRODE WERE SUCCESSFUL. MICRO STIMULATION WAS CONDUCTED. THIS REQUIRED THAT A NEW ELECTRODE BE USED FOR SUBSEQUENT RECORDING. A NEW ELECTRODE WAS INSERTED. PT COMPLAINED OF SEVERE INTRACRANIAL PAIN (SURGERY IS DONE UNDER LOCAL ANESTHESIA). ELECTRODE WAS REMOVED IMMEDIATELY. ALTHOUGH MARKED WITH SAME CATALOG # THE SECOND ELECTRODE WAS INCORRECTLY TOO LONG (228 MM). CORRECT LENGTH WAS 188 MM. PT HAD NO UNTOWARD EFFECTS. ISSUE RESOLVED WITH MFR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * MICROELECTRODE MUV MICRORECORDING SYSTEMS CONSULTANTS * *
    2 * MICROELECTRODE GZL MICRORECORDING SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other