BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 16637189 · Received March 29, 2023

    Report

    Report Number
    1723170-2023-00482
    Event Type
    Malfunction
    Date Received
    March 29, 2023
    Date of Event
    December 23, 2022
    Report Date
    April 19, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    CONTINUATION OF CONCOMITANT MEDICAL PRODUCT: INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: U NK_NAV_COMP, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: PATIENT IDENTIFIER NOT AVAILABLE FROM THE SITE. PATIENT AGE IS THE MEAN VALUE OF PATIENTS IN THE STUDY. PATIENT SEX NOT AVAILABLE FROM THE SITE. 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. 510(K) IS DEPENDENT UPON THE DEVICE MODEL NUMBER AND THEREFORE, 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO ADVERSE EFFECTS DIRECTLY RELATED TO USING THE NAVIGATION SYSTEM.

    Description of Event or Problem · 0

    BELAL, A., VON ALLMEN, G., KOMMURU, I., LANKFORD, J., MOSHER, J. C., SHAH, M. COMPLETE CORPUS CALLOSOTOMY USING A FRAMELESS NAVIGATION PROBE THROUGH A MINICRANIOTOMY IN CHILDREN WITH MEDICALLY REFRACTORY EPILEPSY: A CASE SERIES AND TECHNICAL NOTE. SURGERY NEUROLOGY INTERNATIONAL. 2022. 13(585). DOI: 10.25259/SNI_L 188_2021 ABSTRACT BACKGROUND: MEDICALLY REFRACTORY EPILEPSY CONSTITUTES UP TO ONE-THIRD OF THE EPILEPSY PEDIATRIC PATIENTS. CORPUS CALLOSOTOMY ( CC) HAS BEEN USED FOR THE TREATMENT OF MEDICALLY REFRACTORY EPILEPSY IN CHILDREN WITH ATONIC SEIZURES AND GENERALIZED TONIC-CLONIC ( GTC) SEIZURES. IN THIS CASE SERIES STUDY, WE ARE DESCRIBING A NOVEL TECHNIQUE FOR CC USING THE FRAMELESS NAVIGATION PROBE THROUGH A MINICRANIOTOMY. METHODS: THIRTEEN PEDIATRIC PATIENTS WITH THE DIAGNOSIS OF MEDICALLY REFRACTORY EPILEPSY PREDOMINANTLY GTC WITH DROP ATTACK WHO UNDERWENT EXTENSIVE PHASE I. AN L-SHAPE WAS DONE, THEN THROUGH A 4 X 3 CM CRANIOTOMY, WE WERE ABLE TO OPEN THE INTERHEMISPHERIC FISSURE UNTIL THE CORPUS CALLOSUM IS VISUALIZED. THE STEALTH PROBE IS THEN USED TO GO DOWN TO THE MIDLINE RAPHE WHICH IS FOLLOWED ANTERIORLY THEN TRACED POSTERIORLY TO THE ANTERIOR BORDER OF THE VEIN OF GALEN. FINALLY, THE STEALTH PROBE IS USED TO CONFIRM THE COMPLETENESS OF THE CALLOSOTOMY. RESULTS: THE PROCEDURE WAS ACCOMPLISHED SUCCESSFULLY WITH NO INTRAOPERATIVE COMPLICATIONS; MEAN SURGICAL TIME IS 3 H:07 M. THE MEAN FOLLOW-UP WAS 31.5 MONTHS. ALL PATIENTS ACHIEVED SIGNIFICANT SEIZURE CONTROL. NO PATIENTS EXPERIENCED WORSENING OF THEIR ATONIC SEIZURES AFTER SURGERY COMPARED WITH THEIR PREOPERATIVE STATE; HOWEVER, SIX PATIENTS ACHIEVED ENGEL CLASS I, FOUR PATIENTS ACHIEVED ENGEL CLASS II, AND THREE PATIENTS ACHIEVED ENGEL CLASS III. CONCLUSION: COMPLETE CC USING A FRAMELESS NAVIGATION PROBE IS A NOVEL AND EFFECTIVE TECHNIQUE FOR THE TREATMENT OF MEDICALLY REFRACTORY EPILEPSY WITH A VERY GOOD SURGICAL AND SEIZURE OUTCOMES, MINIMAL NEUROLOGICAL MORBIDITY, MINIMAL BLOOD LOSS, AND SHORT OR TIME. REPORTED EVENTS: ANOTHER PATIENT DEVELOPED POSTOPERATIVE PNEUMONIA WHO RECOVERED AFTER A COURSE OF ANTIBIOTICS. SEE ATTACHED LITERATURE ARTICLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976762 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR Unknown "SEE H10...."