BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 16887198 · Received May 8, 2023

    Report

    Report Number
    1723170-2023-00726
    Event Type
    Death
    Date Received
    May 8, 2023
    Date of Event
    September 1, 2015
    Report Date
    July 27, 2023
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1-A5) PATIENT INFORMATION WAS NOT INCLUDED IN THE JOURNAL ENTRY A2) THIS VALUE REFLECTS THE MEAN AGE OF THE PATIENTS REPORTED IN THE ARTICLE. A3) THIS VALUE REFLECTS THE MAJORITY GENDER OF THE PATIENTS REPORTED IN THE ARTICLE. B2) DATE OF DEATH WAS NOT REPORTED. ESTIMATED EVENT DATE IS USED INSTEAD. B3) THE ARTICLE DID NOT PROVIDE THE DATE OF THE PROCEDURE. THE EVENT DATE IS ESTIMATED FROM THE DATES OF THE STUDY. B5) THE ARTICLE CITATION IS INCLUDED. D4) THE SYSTEM PRODUCT NUMBER AND SERIAL NUMBER WERE NOT PROVIDED IN THE JOURNAL ARTICLE. UDI NOT AVAILABLE FOR THIS SYSTEM. G4) NO 510K PROVIDED AS SYSTEM IS UNKNOWN. H3) NO EVALUATION WAS PERFORMED AS THE EVENT WAS REPORTED AS A LITERATURE ARTICLE. H4) DEVICE MANUFACTURING DATE IS 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

    CITATION: OSTAGAR, ABDULNAIM, ET AL. ¿OUTCOME ANALYSIS OF SURGERIES AROUND CRANIOVERTEBRAL JUNCTION.¿ INTERNATIONAL JOURNAL OF ORTHOPAEDIC SURGERY, VOL. 29, NO. 1, 21 AUG. 2021, P. 3., HTTPS://DOI.ORG/10.4103/IJORS.IJORS_17_21. BACKGROUND: THE CRANIOVERTEBRAL JUNCTION (CVJ) IS MAINLY AFFECTED BY VARIOUS BONY DEVELOPMENTAL ANOMALIES. OTHER CAUSES OF COMPRESSION INCLUDE TRAUMA, TUMORS, ATLANTOAXIAL INSTABILITY, AND INFECTION (TUBERCULAR/PYOGENIC). WE HAVE SURGICALLY TREATED 38 PATIENTS OF CVJ UTILIZING DIFFERENT PROCEDURES OVER A SPAN OF 4 YEARS AND DONE RETROSPECTIVE STUDY. THE PURPOSE OF THIS PAPER IS TO ANALYZE THE OUTCOME OF SURGERIES AROUND CVJ. MATERIALS AND METHODS: IN OUR INSTITUTION, FROM SEPTEMBER 2015 TO AUGUST 2019, 38 PATIENTS UNDERWENT SURGERIES BY DIFFERENT METHODSAROUND CVJ AND A RETROSPECTIVE ANALYSIS WAS DONE. CLINICO-RADIOLOGICAL EVALUATION WAS DONE TO ASSESS THE RESULTS. THE NEUROLOGIC RECOVERY RATE WAS CALCULATED BY JAPANESE ORTHOPAEDIC ASSOCIATION (JOA) SCORE. RESULTS: THERE WERE 31 MALE AND 7 FEMALE PATIENTS IN OUR STUDY WITH A MEAN AGE OF 49.8 YEARS (2¿86 YEARS). THREE (3) ANTERIOR SURGERIES, ONE (1) COMBINED ANTERIOR-POSTERIOR 360º FUSION, AND 34 POSTERIOR SURGERIES INCLUDING 22 ATLANTOAXIAL FIXATIONS WERE DONE. AVERAGE JOA PRE-OP WAS 11.6 (RANGE 4¿16), AT LAST FOLLOW-UP AVERAGE JOA IS 14.1 (RANGE 6¿16). RADIOLOGICALLY, FUSION WAS ACHIEVED IN ALL EXCEPT TWO CASES. CONCLUSION: WE CONCLUDE THAT CVJ PROCEDURES ARE SAFE AND EFFECTIVE, POSTERIOR-ONLY SURGERY GIVES PROMISING RESULTS WITH HIGH FUSION RATE AND NEUROLOGICAL IMPROVEMENT IN MOST OF THE PATIENTS. THE ARTICLE PROVIDES THAT SELECTED PROCEDURES WERE COMPLETED USING MEDTRONIC NAVIGATION AND IMAGING, BUT DOES NOT SPECIFY WHICH PATIENTS AND PROCEDURES USED THEM. IT ALSO DOES NOT SPECIFY RELATEDNESS OR CAUSE OF DEATH OF 2 OF THE PATIENTS NOTED IN THE ARTICLE. 1. TWO PATIENTS DIED WITHIN 1 MONTH OF SURGERY. 2. TWO PATIENTS WITH PAIN WORSENING AT 1-YEAR FOLLOW-UP HAD INITIAL PAIN RELIEF. BOTH FOUND TO HAVE FUSION FAILURE: ONE WITH UNILATERAL C1-C2 SCREW AND ANOTHER WITH CABLE FIXATION. 3. 7 PATIENTS HAD PAIN WITHOUT NEURODEFICIT. 4. ONE MENINGOMYELOCELE PRESENTED WITH SWELLING. 5. 1 ACM TYPE II PRESENTED WITH RECURRENT SYNCOPE AND NEUROFIBROMATOSIS PRESENTED WITH MYOCLONIC JERKS IN LOWER LIMBS. 6. 4 PATIENTS PRESENTED WITH OCCIPITAL NEURALGIA WITHOUT MYELOPATHY. 7. IN THE IMMEDIATE POST-OPERATIVE CARE, TWO PATIENTS DETERIORATED NEUROLOGICALLY. 8. ONE PATIENT HAD TRANSIENT ALTERED SENSORIUM AND IMPROVED OVER 2 DAYS. 9. ONE PATIENT WITH CVJ EPIDURAL ABSCESS HAD INCREASED WEAKNESS OF LIMBS AND NEEDED EXTENDED DECOMPRESSION THE NEXT DAY.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO SUCH INCIDENT THAT COMPLICATION WAS DIRECTLY RELATED TO THE USED IMPLANT FROM MEDTRONIC. THERE WAS ALSO ZERO COMPLICATION DIRECTLY RELATED TO IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955677 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Death