BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 15068831 · Received July 20, 2022

    Report

    Report Number
    1723170-2022-01149
    Event Type
    Injury
    Date Received
    July 20, 2022
    Date of Event
    July 13, 2021
    Report Date
    August 9, 2022
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    GEX
    PMA / PMN Number
    K081656
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT GENDER IS THE MAJORITY VALUE OF PATIENT IN THE STUDY. PATIENT WEIGHT NOT AVAILABLE FROM THE SITE. EVENT DATE IS THE ONLINE PUBLISHING DATE OF THE LITERATURE ARTICLE. DEVICE LOT NUMBER, OR SERIAL NUMBER, UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. DEVICE MANUFACTURING DATE IS DEPENDENT ON LOT NUMBER/SERIAL NUMBER, THEREFORE, UNAVAILABLE. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    RUBINO, F., EICHBERG, D.G., CORDEIRO, J.G., DI, L., ELIAHU, K., SHAH, K., LUTHER, E.M., LU, V.M., KOMOTAR, R.J., IVAN, M.E. ROBOTIC GUIDANCE PLATFORM FOR LASER INTERSTITIAL THERMAL ABLATION AND STEREOTACTIC NEEDLE BIOPSIES: A SINGLE CENTER EXPERIENCE. JOURNAL OF ROBOTIC SURGERY (2022) 16:549¿557 HTTPS://DOI.ORG/10.1007/S11701-021-01278-5. ABSTRACT: WHILE LASER ABLATION HAS BECOME AN INCREASINGLY IMPORTANT TOOL IN THE NEUROSURGICAL ONCOLOGIST¿S ARMAMENTARIUM, DEEP SEATED LESIONS, AND THOSE LOCATED NEAR CRITICAL STRUCTURES REQUIRE UTMOST ACCURACY DURING STEREOTACTIC LASER CATHETER PLACEMENT. ROBOTIC DEVICES HAVE EVOLVED SIGNIFCANTLY OVER THE PAST TWO DECADES BECOMING AN ACCURATE AND SAFE TOOL FOR STEREOTACTIC NEUROSURGERY. HERE, WE PRESENT OUR SINGLE CENTER EXPERIENCE WITH THE MEDTECH ROSA ONE BRAIN ROBOT FOR ROBOTIC GUIDANCE IN LASER INTERSTITIAL THERMAL THERAPY (LITT) AND STEREOTACTIC BIOPSIES. WE RETROSPECTIVELY ANALYZED THE FRST 70 CONSECUTIVE PATIENTS TREATED WITH ROSA DEVICE AT A SINGLE ACADEMIC MEDICAL CENTER. FORTY-THREE PATIENTS RECEIVED NEEDLE BIOPSY IMMEDIATELY FOLLOWED BY LITT WITH THE CATHETER PLACED WITH ROBOTIC GUIDANCE AND 27 RECEIVED STEREOTACTIC NEEDLE BIOPSY ALONE. ALL THE PROCEDURES WERE PERFORMED FRAMELESS WITH SKULL BONE FDUCIALS FOR REGISTRATION. WE REPORT DATA REGARDING INTRAOPERATIVE DETAILS, MORTALITY AND MORBIDITY, DIAGNOSTIC YIELD AND LESION CHARACTERISTICS ON MRI. ALSO, WE DESCRIBE THE SURGICAL WORKFOW FOR BOTH PROCEDURES. THE MEAN AGE WAS 60.3±15 YEARS. THE DIAGNOSTIC YIELD WAS POSITIVE IN 98.5% (N=69). SIXTY-THREE BIOPSIES (90%) WERE SUPRATENTORIAL AND SEVEN (10%) WERE INFRATENTORIAL. GLIOMAS REPRESENTED 54.3% OF THE PATIENTS (N=38). THERE WERE TWO POSTOPERATIVE DEATHS (2.8%). NO PERMANENT MORBIDITY RELATED TO SURGERY WERE OBSERVED. WE DID NOT FND INTRAOPERATIVE TECHNICAL PROBLEMS WITH THE DEVICE. THERE WAS NO NEED TO REPOSITION THE NEEDLE AFTER THE INITIAL PLACEMENT. STEREOTACTIC ROBOTIC GUIDED PLACEMENT OF LASER ABLATION CATHETERS AND BIOPSY NEEDLES IS SAFE, ACCURATE, AND CAN BE IMPLEMENTED INTO A NEUROSURGICAL WORKFOW. REPORTED EVENTS: 5 PATIENTS WITH POSTOPERATIVE COMPLICATION (CLAVIEN-DINDO). ONE PATIENT (1.6%) NEEDED TO BE OPERATED AGAIN BECAUSE OF INCONCLUSIVE RESULT IN PATHOLOGY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT MEDTRONIC WAS NOT THE MANUFACTURER OF THE ROBOT USED IN THE MANUSCRIPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717845 MEDTRONIC NAVIGATION POWERED LASER SURGICAL INSTRUMENT GEX MEDTRONIC NAVIGATION, INC UNK_VISUALASE_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention