BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6719560 · Received July 17, 2017

    Report

    Report Number
    1723170-2017-02954
    Event Type
    Injury
    Date Received
    July 17, 2017
    Date of Event
    December 1, 2016
    Report Date
    July 17, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WEIGHT WAS NOT PROVIDED BY THE AUTHOR(S). THE EXACT SYSTEM INFORMATION COULD NOT BE DETERMINED AS IT WAS NOT PROVIDED. HOWEVER, THE SYSTEM LISTED ON THIS FORM WAS AT THE ADDRESS LISTED IN THE ARTICLE DURING THE TIME SOME OF THE SURGERIES WERE COMPLETED. NO REQUESTS FOR SYSTEM SERVICE HAVE BEEN RECEIVED REGARDING THE REPORTED EVENTS. THE ARTICLE DOES NOT ALLEGE THAT THE MEDTRONIC SYSTEM CAUSED THE REPORTED EVENTS. ARTICLE STATES THIS PATIENT HAD AN ATYPICAL DRTT TRAJECTORY.

    Description of Event or Problem · 1

    CASE STUDY OF IMAGE-GUIDED DEEP BRAIN STIMULATION: MAGNETIC RESONANCE IMAGING BASED WHITE MATTER TRACTOGRAPHY SHOWS DIFFERENCES IN RESPONDERS AND NONRESPONDERS BY O'HALLORAN ET AL, PATIENT 2 (NONRESPONDER) IS A (B)(6) MAN WITH MEDICALLY REFRACTORY PARKINSON DISEASE WHO ALSO UNDERWENT BILATERAL DBS LEAD PLACEMENT IN THE CZI (CAUDAL ZONA INCERTA). HE INITIALLY DEMONSTRATED GREATER THAN 90 PERCENT REDUCTION IN BASELINE TREMOR BUT DEVELOPED DISABLING DYSTONIA OF HIS LEFT LEG AND SIGNIFICANT SLURRING OF HIS SPEECH IN THE MONTHS AFTER SURGERY. POSTOPERATIVE IMAGING SHOWED BILATERAL LEAD PLACEMENT IN THE CZI. RIGHT-SIDED ELECTRODE REVISION WAS RECOMMENDED AND RESULTED IN RELIEF OF TREMOR AND REDUCED DYSTONIC SIDE EFFECTS. TRACTOGRAPHY ANALYSIS OF THE ORIGINAL LEADS REVEALED A DRTT (DENTATORUBROTHALAMIC TRACT) WITH AN ATYPICAL ANTERIOR TRAJECTORY AND A LOCATION OUTSIDE THE FIELD OF STIMULATION. TRACTOGRAPHY ANALYSIS OF THE REVISED LEAD SHOWED A DRTT WITHIN THE FIELD OF STIMULATION. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498916 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention