BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 6370789 · Received March 1, 2017

    Report

    Report Number
    1723170-2017-00930
    Event Type
    Injury
    Date Received
    March 1, 2017
    Date of Event
    August 31, 2014
    Report Date
    June 9, 2017
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450968
    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

    SPECIFIC PATIENT IDENTIFIER NOT AVAILABLE FROM THE JOURNAL ARTICLE/AUTHOR. HOWEVER, 2 WAS USED AS THIS PATIENT WAS REPORTED AS CASE 2. PATIENT WEIGHT WAS NOT PROVIDED BY THE JOURNAL ARTICLE AUTHORS. EVENT DATE IS APPROXIMATED AS THE EXACT DATES WERE NOT MADE AVAILABLE. THE PROCEDURES WERE REPORTED TO HAVE OCCURRED THROUGH (B)(6) 2014, THEREFORE (B)(6) 2014, WAS USED. CITATION: THIABPHA, A., HANSASUTA, A. INITIAL EXPERIENCE WITH ULTRA-LOW-FIELD INTRAOPERATIVE MAGNETIC RESONANCE IMAGING IN ENDOSCOPIC ENDONASAL TRANSSPHENOIDAL SURGERY FOR PITUITARY. J MED ASSOC THAI 2016; 99 (SUPPL. 3): S30-S38. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. PER THE ARTICLE, ADVANCE IN STEREOTACTIC NAVIGATION HAS BEEN SHOWN TO AID TUMOR RESECTION IN ADDITION TO SAFE GUIDANCE FOR TSS. HOWEVER, NAVIGATION SYSTEM LACKS REAL-TIME FEEDBACK TO PROPERLY ASSURE SURGEON OF THE COMPLETE PA RESECTION. AS A RESULT, DESPITE SOPHISTICATED SURGICAL DEVICES, RESIDUAL PA AFTER TSS HAS BEEN REPORTED TO BE 15% TO 70%. NO REQUEST FOR SERVICE HAVE BEEN RECEIVED FROM THE CUSTOMER REGARDING THESE EVENTS. NO PARTS HAVE BEEN REPLACED OR RETURNED TO THE MANUFACTURER. JOURNAL ARTICLE; NOT RETURNED BY CUSTOMER.

    Additional Manufacturer Narrative · 1

    UPON FURTHER MULTI-DISCIPLINARY TEAM REVIEW, IT WAS FOUND THAT THERE ARE NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    PER ATTACHED ARTICLE, FORWARDED BY A MEDTRONIC REPRESENTATIVE, THE USE OF THE NAVIGATION SYSTEM AND IMAGING SYSTEM ENDOSCOPIC TRANSSPHENOIDAL SURGERY FOR PITUITARY ADENOMA (PA) WAS REPORTED. THIS IS TWO OF TWO REPORTS. FROM (B)(6) 2013 TO (B)(6) 2014, A TOTAL OF 29 PATIENTS HAD INTRAOPERATIVE MAGNETIC RESONANCE IMAGING (IMRI) FOR THEIR INTRACRANIAL SURGERIES. THERE WERE 11 PATIENTS THAT MET THE FULL CRITERIA AND THEIR PATIENTS¿ DATA ARE SHOWN IN TABLE 1. A (B)(6)-YEAR-OLD MALE PATIENT (CASE NO. 2 FROM TABLE 1), WITH PROGRESSIVE DETERIORATION OF VISION, WAS FOUND TO HAVE GIANT NON-FUNCTIONING PITUITARY MACROADENOMA. THE PATIENT UNDERWENT ENDOSCOPIC TRANSSPHENOIDAL SURGERY (ETSS) USING IMRI. AT THE END OF TUMOR RESECTION, AFTER THE SURGEON BELIEVED THERE WAS NO ENDOSCOPICALLY-VISIBLE RESIDUAL PA, THE FIRST POSTOPERATIVE IMRI SCAN WAS OBTAINED AND WAS SHOWN TO HAVE TUMOR REMNANT IN SPITE OF SURGEON¿S IMPRESSION OF TOTAL TUMOR REMOVAL. THIS FINDING PROMPTED FURTHER RESECTION USING GUIDANCE FROM A NAVIGATOR, BASED ON THE NEWLY ACQUIRED DATA OF THE FIRST POSTOPERATIVE IMRI SCANNING, UNTIL THERE WAS NO TUMOR LEFT. A SECOND POSTOPERATIVE IMRI REVEALED NO TUMOR REMNANT. SURGERY WAS THEREFORE FINISHED AFTER THIS IMRI FINDINGS. ONE YEAR AFTER HIS ETSS, THERE WAS NO EVIDENCE OF RESIDUAL TUMOR. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150474 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR Other| R