BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEEP BRAIN STIMULATOR

    MDR report key: 1209594 · Received October 23, 2008

    Report

    Report Number
    2182207-2008-06821
    Event Type
    Injury
    Date Received
    October 23, 2008
    Report Date
    September 25, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: GLOSSOP A, DOBBS P, CORONARY ARTERY VASOSPASM DURING AWAKE DEEP BRAIN STIMULATION SURGERY. BR J ANAESTH. 2008;101(2):222-224. AS PTS ARE AWAKE DURING DEEP BRAIN STIMULATION (DBS) SURGERY AND MAY BE UNDER CONSIDERABLE DISTRESS SHOULD VASOSPASM OCCUR, BASED ON THE PRESENT CASE REPORT, IT IS OUR OPINION THAT IN ALL CASES OF DBS SURGERY, FULL PT MONITORING SHOULD BE MANDATORY AND AN ANESTHETIST SHOULD BE PRESENT THROUGHOUT THE CASE. THIS ARTICLE DESCRIBES TWO PTS WHO DEMONSTRATED SIGNIFICANT CORONARY ARTERY VASOSPASM THAT OCCURRED DURING PLACEMENT OF THE STIMULATING ELECTRODES FOR AWAKE DBS. REPORTABLE EVENT: A FEMALE WITH PARKINSON'S SYNDROME UNDERWENT BILATERAL PALLIDAL STIMULATION. DURING ADVANCEMENT OF THE ELECTRODE TOWARDS THE TARGET, THE PT SUFFERED CRUSHING CENTRAL CHEST PAIN, BECAME CLAMMY, NAUSEATED, HYPERTENSIVE TO 180/80 MM HG AND TACHYCARDIC, AND DESATURATED (OXYGEN SATURATION 70%). THE PT WAS TREATED WITH SUBLINGUAL GLYCERYL TRINITRATE (GTN), OXYGEN, AND DIAMORPHINE AND THE PROCEDURE ABANDONED AFTER SECURING THE ELECTRODE. SHE MADE AN UNEVENTFUL RECOVERY AND CORONARY ANGIOGRAPHY 6 DAYS LATER SHOWED NORMAL CORONARY ARTERY VASCULATURE; A DIAGNOSIS OF CORONARY ARTERY VASOSPASM WAS MADE BY THE CONSULTANT CARDIOLOGIST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention PROGRAMMER MODEL UNK N=1| EXTENSION MODEL UNK N=2| LEAD MODEL UNK N=2