BEUDAMED
    FDA Adverse Event Death Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 21388288 · Received February 14, 2025

    Report

    Report Number
    2182207-2025-00460
    Event Type
    Death
    Date Received
    February 14, 2025
    Date of Event
    December 24, 2024
    Report Date
    February 14, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE WILL BE SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. D10. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, CITATION: SOBSTYL, M., KARAMON, K. STAPINSKA-SYNIEC, A. COMPARATIVE ANALYSIS OF HEMORRHAGIC COMPLICATIONS IN DBS: MICROELECTRODE RECORDING VS. MACROSTIMULATION - DOES THE TECHNIQUE MATTER? WORLD NEUROSURG. 123634 (2024) DOI: 10.1016/J.WNEU.2024.123634. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING "COMPARATIVE ANALYSIS OF HEMORRHAGIC COMPLICATIONS IN DBS: MICROELECTRODE RECORDING VS. MACROSTIMULATION - DOES THE TECHNIQUE MATTER?" BACKGROUND: HEMORRHAGE IS A DANGEROUS COMPLICATION OF DEEP BRAIN STIMULATION (DBS) SURGERY, BUT A COMPREHENSIVE EXPLANATION OF THE A SSOCIATED RISK FACTORS REMAINS INCONCLUSIVE, PARTICULARLY APPLICATION OF MICROELECTRODE RECORDING (MER) COMPARED WITH MACROSTIMULATION (NON-MER)-BASED DBS PROCEDURES. WE CONDUCTED A COMPARATIVE ANALYSIS OF MER AND MACROSTIMULATION TECHNIQUES, EVALUATING THE IMPACT OF BRAIN PENETRATIONS BY MICROELECTRODE GUIDING CANNULAS ON THE OCCURRENCE OF INTRACRANIAL HEMORRHAGIC EVENTS. METHODS: THIS RETROSPECTIVE STUDY INCLUDED ALL DBS PROCEDURES (MER-BASED AND NON-MEREBASED) PERFORMED AT A SINGLE MEDICAL CENTER FROM NOVEMBER 2008 TO JUNE 2023. PATIENTS UNDERWENT COMPREHENSIVE PREOPERATIVE AND POSTOPERATIVE EVALUATIONS, INCLUDING POSTOPERATIVE COMPUTED TOMOGRAPHY TO ASSESS LEAD PLACEMENT AND INTRACRANIAL BLEEDING, CATEGORIZED AS SYMPTOMATIC OR ASYMPTOMATIC. STATISTICAL ANALYSES WERE CONDUCTED TO ASCERTAIN THE CORRELATION BETWEEN DIFFERENT SURGICAL TECHNIQUES AND THE RISK OF HEMORRHAGIC COMPLICATIONS. RESULTS: IN A COHORT OF 618 PATIENTS, 1096 ELECTRODES WERE IMPLANTED DURING 672 CONSECUTIVE DBS PROCEDURES. THERE WERE 21 ASYMPTOMATIC AND 6 SYMPTOMATIC INTRACRANIAL HEMORRHAGES (ICHS), INCLUDING 1 DEATH. THE BLEEDING RATE WAS 4.37% PER PATIENT AND 2.92% PER ELECTRODE. PATIENTS WHO DEVELOPED HEMATOMAS WERE MORE PREVALENT IN THE MER GROUP (25 CASES) COMPARED WITH THE NON-MER GROUP (2 CASES). THE MER GROUP HAD A HIGHER MEAN NUMBER OF BRAIN PENETRATIONS BY GUIDING CANNULAS. CONCLUSIONS: DBS PROCEDURES ARE GENERALLY SAFE, WITH ONLY 0.97% RESULTING IN LONG-TERM OR PERMANENT DEFICITS. ALL SYMPTOMATIC ICH OC CURRED IN MER-BASED PROCEDURES, WHEREAS MACROSTIMULATION WAS ASSOCIATED WITH ONLY 2 ASYMPTOMATIC ICH CASES. THE HIGHER NUMBER OF BRAIN PENETRATIONS IN MER CORRELATES WITH HIGHER BLEEDING RATES. REPORTED EVENTS: OF THE 27 PATIENTS WITH INTRACRANIAL HEMORRHAGE (ICH), 22 PATIENTS HAD PARKINSON'S DISEASE, IN WHICH, 5 PATIENTS EXPERIENCED PERMANENT DEFICITS AFTER THE ICH AND 1 DEATH. ALL PATIENTS DIAGNOSED WITH ICH WERE CLOSELY MONITORED AND MANAGED IN THE INTENSIVE CARE UNIT. ALL PATIENTS WITH SYMPTOMATIC ICH, WHO SURVIVED THE OPERATION, REQUIRED COMPREHENSIVE REHABILITATION THROUGHOUT THEIR EXTENDED HOSPITALIZATION IN THE NEUROSURGERY DEPARTMENT, FOLLOWED BY A NEUROLOGIC REHABILITATION FACILITY AT THE INSTITUTION. WITHIN THE STUDY GROUP, 5 PATIENTS SHOWED HEMORRHAGE ASSOCIATED WITH BOTH ELECTRODES, ACCOUNTING FOR 32 ELECTRODES DIRECTLY LINKED TO INTRACRANIAL BLEED AND AN OVERALL BLEEDING RATE OF 2.92% PER IMPLANTED ELECTRODE. - PATIENT 12: 66/M, TYPE OF ICH AND LOCATION: INTRAVENTRICULAR BLEEDING INTO THE THIRD, FOURTH, AND LATERAL VENTRICLES, INTRAPARENCHYMAL BLEEDING IN THE LEFT FRONTAL LOBE, BLEEDING TO CEREBELLOMEDULLARY CISTERN, RESULTING IN DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1126471 IMPLANTABLE NEUROSTIMULATOR Stimulator, electrical, implanted, for parkinsonian tremor MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Death "SEE H11...."