BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC NAVIGATION

    MDR report key: 18652446 · Received February 6, 2024

    Report

    Report Number
    1723170-2024-00456
    Event Type
    Injury
    Date Received
    February 6, 2024
    Date of Event
    October 10, 2023
    Report Date
    February 6, 2024
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B2: NO INTERVENTION WAS NOTED FOR ANY OF THE ADVERSE EVENTS REPORTED. H3, H6: NO PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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: WORLD NEUROSURG. (2024) 181:E346-E355. HTTPS://DOI.ORG/10.1016/J.WNEU.2023.10.053 SUMMARY: BACKGROUND: DEEP BRAIN STIMULATION OF THE SUBTHALAMIC NUCLEUS (STN-DBS) FOR PARKINSON¿S DISEASE CAN BE PERFORMED WITH INTRAOPERATIVE NEUROPHYSIOLOGICAL AND RADIOGRAPHIC GUIDANCE. CONVENTIONAL T2-WEIGHTED MAGNETIC RESONANCE IMAGING SEQUENCES, HOWEVER, OFTEN FAIL TO PROVIDE DEFINITIVE BORDERS OF THE STN. NOVEL MAGNETIC RESONANCE IMAGING SEQUENCES, SUCH AS SUSCEPTIBILITY-WEIGHTED IMAGING (SWI), MIGHT BETTER LOCALIZE THE STN BORDERS AND FACILITATE RADIOGRAPHIC TARGETING. WE COMPARED THE RADIOGRAPHIC LOCATION OF THE DORSAL AND VENTRAL BORDERS OF THE STN USING SWI WITH INTRAOPERATIVE MICROELECTRODE RECORDING (MER) DURING AWAKE STN-DBS FOR PARKINSON¿S DISEASE. -METHODS: THIRTEEN CONSECUTIVE PATIENTS WHO UNDERWENT PLACEMENT OF 24 STN-DBS LEADS FOR PARKINSON¿S DISEASE WERE ANALYZED RETROSPECTIVELY. PREOPERATIVE TARGETING WAS PERFORMED WITH SWI, AND MER DATA WERE OBTAINED FROM INTRAOPERATIVE ELECTROPHYSIOLOGY RECORDS. THE BOUNDARIES OF THE STN ON SWI WERE IDENTIFIED BY A BLINDED INVESTIGATOR. -RESULTS: THE FINAL ELECTRODE POSITION DIFFERED SIGNIFICANTLY FROM THE PLANNED COORDINATES IN DEPTH BUT NOT IN LENGTH OR WIDTH, INDICATING THAT MER GUIDED THE FINAL ELECTRODE DEPTH. WHEN WE COMPARED THE BOUNDARIES OF THE STN BY MER AND SWI, SWI ACCURATELY PREDICTED THE ENTRY INTO THE STN BUT UNDERESTIMATED THE LENGTH AND VENTRAL BOUNDARY OF THE STN BY 1.2 MM. THIS EXTENT OF ERROR APPROXIMATES THE SPAN OF A DBS CONTACT AND COULD AFFECT THE PLACEMENT OF DIRECTIONAL CONTACTS WITHIN THE STN. CONCLUSIONS: MER MIGHT CONTINUE TO HAVE A ROLE IN STN-DBS. THIS COULD POTENTIALLY BE MITIGATED BY FURTHER REFINEMENT OF IMAGING PROTOCOLS REPORTED EVENT(S): THIRTEEN CONSECUTIVE PATIENTS WHO UNDERWENT PLACEMENT OF 24 STN-DBS LEADS FOR PARKINSON¿S DISEASE WERE ANALYZED RETROSPECTIVELY. THE PATIENTS WERE AGED 5-74 YEARS. THERE WERE 11 MEN AND 2 WOMEN. THE MEAN PLANNED DEEP BRAIN STIMULATION (DBS) X COORDINATE WAS 11.2 +/- .9, AND THE MEAN ACTUAL TARGET X COORDINATE WAS 10.1 +/- 1.2. THE MEAN DBS RADIAL ERROR FOR THE PLANNED X COORDINATE WAS 11.2 +/- .9, AND THE MEAN TARGET X COORDINATE WAS 10.9 +/- 1.2. THE MEAN PLANNED DEEP BRAIN STIMULATION (DBS) Y COORDINATE WAS -2.6 +/- .7, AND THE MEAN ACTUAL TARGET Y COORDINATE WAS -3.8 +/- 1.0. THE MEAN DBS RADIAL ERROR FOR THE PLANNED Y COORDINATE WAS -2.6 +/- .7, AND THE MEAN Y TARGET COORDINATE WAS -2.7+/- 1.2. THE MEAN PLANNED DEEP BRAIN STIMULATION (DBS) Z COORDINATE WAS -4.8 +/- .8, AND THE MEAN ACTUAL TARGET Z COORDINATE WAS -6.9 +/- 1.3. THE MEAN RADIAL ERROR AT TARGET WAS 1.1 +/- .7. PATIENT 4 EXPERIENCED THE SIDE EFFECT OF SPEECH DYSARTHRIA WITH OPTIMAL TREMOR CONTROL, WHICH WAS DETERMINED TO BE TOLERABLE BY THE PATIENT. PATIENT 7 EXPERIENCED MILD TOE CRAMPING WITH OPTIMAL PROGRAMMING, WHICH WAS ALSO TOLERABLE, GIVEN THEIR ACHIEVED SYMPTOM CONTROL. PATIENT 11 HAD SOME MILD BRADYKINESIA OF THE LEFT FOOT BUT OTHERWISE HAD RESOLUTION OF TREMOR AND RIGIDITY SYMPTOMS. PATIENT 13 EXPERIENCED MILD SPEECH DYSARTHRIA, WHICH WAS ALSO DEEMED TO BE TOLERABLE BY THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2091578 MEDTRONIC NAVIGATION NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC UNK_NAV_SYS

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Other