BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION TRIA NAVIGATION SYSTEM

    MDR report key: 6310465 · Received February 8, 2017

    Report

    Report Number
    1723170-2017-00377
    Event Type
    Injury
    Date Received
    February 8, 2017
    Date of Event
    March 31, 2014
    Report Date
    February 8, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    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

    PATIENT IDENTIFIER WAS NOT PROVIDED BY THE JOURNAL ARTICLE AUTHOR. PATIENT SPECIFIC AGES WERE NOT PROVIDED; AGE RANGE 67.7+/-10.9 YEARS, THEREFORE (B)(6) YEARS WAS USED. PATIENT SEX WAS NOT PROVIDED. THERE WERE 31 MALE, 54 FEMALE; THEREFORE FEMALE WAS USED. PATIENT WEIGHT WAS NOT PROVIDED BY THE JOURNAL ARTICLE AUTHOR. EVENT DATE IS APPROXIMATED AS THE EXACT DATES WERE NOT MADE AVAILABLE. STUDY TIME FRAME WAS THROUGH MARCH 2014, THEREFORE (B)(6) 2014 WAS USED. CITATION: WANG, N., & HU, Y. (2016). CLINICAL EFFICACY OF THE COMBINATION OF NEURONAVIGATION AND ELECTRO-PHYSIOLOGICAL MONITORING TECHNIQUES PERCUTANEOUS RADIOFREQUENCY THERMOCOAGULATION THERAPY FOR THE TREATMENT OF TRIGEMINAL NEURALGIA, 22(11), 823-827. DOI:10.3969/J.ISSN.1006-9852.2016.11.006 DEVICE UDI NOT PROVIDED AS THIS PRODUCT IS NO LONGER MANUFACTURED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    THE AUTHORS REPORTED USE OF A NAVIGATION SYSTEM AND THERE WERE PATIENT EVENTS REPORTED. THE ARTICLE IS IN CHINESE AND WAS SUMMARIZED BY MEDTRONIC REPRESENTATIVES. THE STUDY INCLUDED 85 PATIENTS. INDICATION OF PERCUTANEOUS RADIOFREQUENCY (RF) THERMOCOAGULATION TO TREAT TRIGEMINAL NEURALGIA AND GUIDED BY THE NAVIGATION SYSTEM. THE STUDY TIME FRAME WAS APRIL 2013 THROUGH MARCH 2014. ADVERSE EVENTS SUMMARIZED: DURING PREOPERATIVE NAVIGATION RECONSTRUCTION, IT WAS NOTED THAT 2 PATIENTS HAD A LONG, FLAT FORAMEN OVALE, WITH AN ANGLE DIFFERENT FROM OTHER PATIENTS. PUNCTURE WAS NOT SUCCESSFUL ON THE FIRST ATTEMPT IN THESE 2 PATIENTS, AND WAS PAINFUL. THE SURGEONS THEN DESIGNED A NEW ROUTE OF PUNCTURE, AND UNDER REAL-TIME NAVIGATION, SUCCESSFULLY COMPLETED THE PROCEDURE; PATIENTS DID NOT REPORT MUCH PAIN. POST-OPERATIVE: IN 8 PATIENTS, BECAUSE OF POSTOPERATIVE NUMBNESS, THEY BIT THE INSIDE OF THEIR MOUTH WHILE EATING, RESULTING IN ORAL ULCER. SYMPTOMS IMPROVED OR CLEARED AFTER TREATMENT. THREE (3) PATIENTS HAD JAW MUSCLE WEAKNESS ON THE SIDE OF SURGICAL TREATMENT, BUT DID NOT AFFECT ABILITY TO EAT, AND THERE WAS SIGNIFICANT IMPROVEMENT OVER TIME. TWELVE (12) PATIENTS HAD BLURRY VISION, PHOTOPHOBIA, OR TEARY EYE ON THE SIDE OF SURGICAL TREATMENT. SYMPTOMS WERE ALLEVIATED WITH TREATMENT (BEIFUSHU EYEDROPS (BFGF) OR ERYTHROMYCIN OINTMENT) 1 PATIENT HAD CSF LEAK 1 MONTH AFTER SURGERY. SYMPTOMS DISAPPEARED AFTER TREATMENT WAS GIVEN. 1 PATIENT DEVELOPED KERATITIS ON THE SIDE OF SURGICAL TREATMENT, CONDITION IMPROVED AFTER TREATMENT. NO FURTHER DETAILS WERE PROVIDED OR ADDITIONAL INFORMATION ON ADVERSE EVENTS. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S 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
    95309 STEALTHSTATION TRIA NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) TRIA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Life Threatening| R