BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 6341693 · Received February 17, 2017

    Report

    Report Number
    1723170-2017-00434
    Event Type
    Injury
    Date Received
    February 17, 2017
    Date of Event
    August 14, 2012
    Report Date
    June 20, 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 IDS AND WEIGHTS WERE NOT PROVIDED BY THE AUTHOR(S). NO ALLEGATION OF ANY MEDTRONIC NAVIGATION SOFTWARE/SYSTEM MALFUNCTION. NO REQUESTS FOR SERVICE HAVE BEEN RECEIVED FROM THE AUTHOR(S) REGARDING THE REPORTED EVENT. THEREFORE, NO SYSTEM EVALUATION IS REQUIRED. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S I7 STEALTHSTATION. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT COMPLICATIONS AS THEY ARE KNOWN INHERENT RISKS TO THIS TYPE OF SURGERY.

    Additional Manufacturer Narrative · 1

    UNIQUE DEVICE IDENTIFICATION (UDI) UPDATED TO PROPER VALUE.

    Description of Event or Problem · 1

    PER ARTICLE, "CLINICAL EXPERIENCE OF 3T INTRAOPERATIVE MAGNETIC RESONANCE IMAGING INTEGRATED NEUROSURGICAL SUITE IN SHANGHAI HUASHAN HOSPITAL" BY QIU ET AL, FROM SEPTEMBER 2010 THROUGH MARCH 2012, 373 CONSECUTIVE PATIENTS UNDERWENT NEUROLOGICAL SURGERY UNDER GUIDANCE WITH 3T IMRI (IMRIS) AND THE MEDTRONIC I7 NAVIGATION SYSTEM. A RETROSPECTIVE ANALYSIS WAS CONDUCTED REGARDING CLINICAL EFFICIENCY. RESULTS ALL SURGERY IN THE 373 PATIENTS WAS SAFE. THE RATIO OF GROSS TOTAL RESECTION FOR CEREBRAL GLIOMAS (N=161) WAS INCREASED FROM 55.90% TO 87.58%. THE RATIO OF BENEFIT IN EXTENT OF RESECTION WAS 39.13%. ONE HUNDRED AND FIFTY EIGHT OF THE 161 GLIOMA PATIENTS ACCOMPLISHED FOLLOW-UP AT 3 MONTHS POSTOPERATIVELY. TWENTY OF 161 PATIENTS (12.42%) SUFFERED FROM EARLY MOTOR DEFICIT AFTER SURGERY. LATE MOTOR DEFICIT WAS HOWEVER OBSERVED IN FIVE OF 158 PATIENTS (3.16%). TWENTY-ONE OF 161 PATIENTS (13.04%) HAD EARLY SPEECH DEFICIT AND LATE SPEECH DEFICIT WAS ONLY OBSERVED IN SIX OF 158 PATIENTS (3.80%). THE RATIO OF GROSS TOTAL RESECTION FOR PITUITARY ADENOMAS (N=49) WAS INCREASED FROM 77.55% TO 85.71%. THE RATIO OF BENEFIT IN EXTENT OF RESECTION WAS 10.2%. THERE WERE 373 CASES, INCLUDING 125 MALE AND 248 FEMALE, AGED FROM 5 TO 78 YEARS (MEAN: 45.5 YEARS). BOTH PREOPERATIVE AND POSTOPERATIVE TUMOR VOLUMES OF 161 PATIENTS WHO UNDERWENT CRANIOTOMY FOR GLIOMA RESECTION WERE ACQUIRED. THE MEAN PREOPERATIVE LESION VOLUME WAS 59.24 CM3. IMRI REVEALED THAT 90 OF 161 CASES (55.90%) ACHIEVED GTR AND 71 HAD GLIOMA RESIDUE, OF WHICH 63 CASES (88.73%) REQUIRED FURTHER RESECTION, WHICH GAVE A BENEFIT RATIO WAS OF 39.13% (63/161). ALTHOUGH EIGHT CASES REVEALED TUMOR RESIDUE IN ELOQUENT AREAS, THE AMOUNT OF TUMOR RESECTED REACHED PREOPERATIVE SURGICAL PLANNING EXPECTATIONS AND REQUIRED NO FURTHER RESECTION. AMONG THE 63 CASES THAT REQUIRED FURTHER RESECTION, IMRI CONFIRMED THAT 45 CASES ACHIEVED GTR, WITH THE REMAINING 18 CASES STILL SUGGESTING TUMOR RESIDUE. SIX CASES ACHIEVED GTR AND 12 HAD TUMOR RESIDUE ADJACENT TO CRITICAL AREAS THAT WARRANTED NO ADDITIONAL SURGERY. EVENTUALLY, 141 GLIOMAS (87.58%, 141/161) ACHIEVED GTR IN 161 CRANIOTOMIES. THEREFORE, THE GTR RATE FOR PATIENTS IMPROVED FROM 55.90% (90/161) TO 87.58% (141/161). ONE HUNDRED AND FIFTY-ONE OPERATIONS REQUIRED FUNCTIONAL NEURONAVIGATION GUIDANCE DUE TO THE PROXIMITY OF THE TUMOR AND SURROUNDING ELOQUENT CORTEX AND SUBCORTICAL TRACTS. TWENTY OF 161 PATIENTS (12.42%) SUFFERED FROM EARLY MOTOR DEFICIT AFTER SURGERY. FOLLOW-UP AT 3 MONTHS FOR 158 PATIENTS SUGGESTED FIVE PATIENTS (3.16%) HAD LATE MOTOR DEFICIT. TWENTY-ONE OF 161 PATIENTS (13.04%) PRESENTED WITH EARLY SPEECH DEFICIT. FOLLOW-UP AT 3 MONTHS REVEALED THAT LATE LANGUAGE DEFICITS WERE OBSERVED IN SIX OF 158 PATIENTS (3.80%). SEVEN OF 161 PATIENTS (4.35%) PRESENTED WITH SEVERE POSTOPERATIVE INTRACRANIAL HEMATOMA WHICH REQUIRED REOPERATION; ONE DIED FROM SEVERE INFECTION AND MULTIPLE ORGAN FAILURE. OF THE 49 TRANS-SPHENOIDAL PITUITARY TUMOR RESECTION CASES, HISTOPATHOLOGY CONFIRMED THAT 31 WERE NONFUNCTIONING PITUITARY ADENOMAS. THIRTY-EIGHT OF 49 CASES (77.55%) ACHIEVED GTR, WHILE 11 CASES SHOWED TUMOR RESIDUE ON IMRI; FIVE OF WHICH REQUIRED FURTHER RESECTION AND FOUR EVENTUALLY ACHIEVED GTR. FINALLY, 42 OF 49 PITUITARY ADENOMAS ACHIEVED GTR (85.71%). THE BENEFIT RATIO WAS 10.20% (5/49). THE TOTAL RESECTION RATE IMPROVED FROM 77.55% (38/49) TO 85.71% (42/49). AMONG 25 IMRI-GUIDED BIOPSIES, ALL HISTOPATHOLOGICAL DIAGNOSES WERE CONFIRMED, COMPRISING 14 GLIOMAS, SEVEN LYMPHOMAS, THREE INFLAMMATORY GRANULOMAS, AND ONE GERMINOMA. THE EMERGENCE OF IMAGE-GUIDED NEUROSURGERY HAS DRASTICALLY REVOLUTIONIZED NEUROSURGICAL PROCEDURES, YET BRAIN SHIFT IS ONE OF ITS LIMITATIONS, DECREASING BOTH ACCURACY AND SAFETY OF SURGERY. NOTE: A NON-MEDTRONIC IMAGING SYSTEM WAS UTILIZED FOR THESE PROCEDURES. 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. 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
    122346 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) I7

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Disability