BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 PLANNING STATION

    MDR report key: 6607140 · Received June 2, 2017

    Report

    Report Number
    1723170-2017-02305
    Event Type
    Injury
    Date Received
    June 2, 2017
    Date of Event
    January 1, 2015
    Report Date
    June 1, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994532398
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT IDS OR WEIGHTS WERE PROVIDED BY THE AUTHORS. LE GOFF F, DERREY S, LEFAUCHEUR R, ET AL. DECLINE IN VERBAL FLUENCY AFTER SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN PARKINSON¿S DISEASE: A MICROLESION EFFECT OF THE ELECTRODE TRAJECTORY? JOURNAL OF PARKINSON¿S DISEASE 5 (2015) 95¿104 DOI 10.3233/JPD-140443. 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 THE SURGERIES WERE COMPLETED AND HAS THE SOFTWARE INSTALLED WHICH WAS USED. 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. REPORTED EVENTS ARE KNOWN INHERENT RISKS TO THIS PROCEDURE TYPE. IT IS UP TO THE SURGEON'S DISCRETION WHERE TO PLACE THE TRAJECTORY.

    Description of Event or Problem · 1

    THE JOURNAL ARTICLE, DECLINE IN VERBAL FLUENCY AFTER SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION IN PARKINSON¿S DISEASE: A MICROLESION EFFECT OF THE ELECTRODE TRAJECTORY? BY LE GOFF ET AL, WAS REVIEWED AND IT WAS FOUND THAT ADVERSE EVENTS WERE REPORTED. MEDTRONIC FRAMELINK SOFTWARE WAS USED TO PLAN LEAD PLACEMENT. PLEASE SEE ARTICLE EXCERPTS BELOW FOR FURTHER DETAILS: "THE ARTICLE REPORTS THAT A SIGNIFICANT DECLINE OF BOTH SEMANTIC AND PHONEMIC VF (VERBAL FLUENCY) WAS FOUND AFTER SURGERY, RESPECTIVELY 14.9%±22.1 (P < 0.05) AND 14.2%±30.3 (P < 0.05). PATIENTS WHO DECLINED IN SEMANTIC VF (N = 44) HAD A LEFT TRAJECTORY WITH A MORE ANTERIOR CORTICAL ENTRY POINT (56±53 VERSUS 60±55 DEGREE, P = 0.01) PASSING LESS FREQUENTLY TROUGH THE THALAMUS (P = 0.03). CONCLUSIONS: MICROLESION OF LEFT BRAIN REGIONS MAY CONTRIBUTE TO SUBTLE COGNITIVE IMPAIRMENT FOLLOWING STN-DBS IN PD." WHILE MEDTRONIC'S FRAMELINK SOFTWARE WAS USED TO PLAN THE TRAJECTORIES. THERE IS NO INDICATION THAT THE TRAJECTORIES USED WERE ANYTHING OTHER THAN WHAT THE SURGEON INTENDED, ONLY THAT WHEN LEFT SIDED TRAJECTORIES WITH MORE ANTERIOR CORTICAL ENTRY POINTS WERE USED, THIS CORRELATED WITH DECLINE IN POSTOPERATIVE SEMANTIC VERBAL FLUENCY. 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 NAVIGATION PLANNING SYSTEM. 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
    390475 STEALTHSTATION S7 PLANNING STATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 PLANNING STATION 00613994532398

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability