BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 16211771 · Received January 19, 2023

    Report

    Report Number
    2182207-2023-00116
    Event Type
    Injury
    Date Received
    January 19, 2023
    Date of Event
    November 17, 2022
    Report Date
    January 19, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ID NEU_INS_STIMULATOR, SERIAL/LOT#: UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: KRAUSE, P., REIMER, J., KAPLAN, J., BORNGRÄBER, F., SCHNEIDER, G-H., FAUST, K., AND KÜHN, AA. (2022) DEEP BRAIN STIMULATION IN EARLY ONSET PARKINSON¿S DISEASE. FRONT. NEUROL. 13:1041449. DOI: 10.3389/FNEUR.2022.1041449 A.2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. 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

    KRAUSE, P., REIMER, J., KAPLAN, J., BORNGRÄBER, F., SCHNEIDER, G-H., FAUST, K., AND KÜHN, AA. (2022) DEEP BRAIN STIMULATION IN EARLY ONSET PARKINSON¿S DISEASE. FRONT. NEUROL. 13:1041449. DOI: 10.3389/FNEUR.2022.1041449 SUMMARY: INTRODUCTION: SUBTHALAMIC DEEP BRAIN STIMULATION (STN-DBS) IS A SAFE AND WELL-ESTABLISHED THERAPY FOR THE MANAGEMENT OF MOTOR SYMPTOMS REFRACTORY TO BEST MEDICAL TREATMENT IN PATIENTS WITH PARKINSON¿S DISEASE (PD). EARLY INTERVENTION IS DISCUSSED ESPECIALLY FOR EARLY-ONSET PD (EOPD) PATIENTS THAT PRESENT WITH AN AGE OF ONSET = 45¿50 YEARS AND SEE THEMSELVES OFTEN CONFRONTED WITH HIGH PSYCHOSOCIAL DEMANDS. METHODS: WE RETROSPECTIVELY ASSESSED THE EFFECT OF STN-DBS AT 12 MONTHS FOLLOW-UP (12-MFU) IN 46 EOPD-PATIENTS. EFFECTS OF STIMULATION WERE EVALUATED BY COMPARISON OF DISEASE-SPECIFIC SCORES FOR MOTOR AND NON-MOTOR SYMPTOMS INCLUDING IMPULSIVENESS, APATHY, MOOD, QUALITY OF LIFE (QOL), COGNITION BEFORE SURGERY AND IN THE STIMULATION ON-STATE WITHOUT MEDICATION. FURTHER, CHANGE IN LEVODOPA EQUIVALENT DOSAGE (LEDD) AFTER SURGERY, DBS PARAMETER, LEAD LOCALIZATION, ADVERSE AND SERIOUS ADVERSE EVENTS AS WELL AS AND POSSIBLE ADDITIONAL CLINICAL FEATURES WERE ASSESSED. RESULTS: PD-ASSOCIATED GENE MUTATIONS WERE FOUND IN 15% OF OUR EOPD-COHORT. AT 12-MFU, MEAN MOTOR SCORES HAD IMPROVED BY 52.4 ± 17.6% IN THE STIM-ON/MED-OFF STATE COMPARED TO THE MED-OFF STATE AT BASELINE (P = 0.00; N = 42). THESE IMPROVEMENTS WERE ACCOMPANIED BY A SIGNIFICANT 59% LEDD REDUCTION (P <(><<)> 0.001), A SIGNIFICANT 6.6 ± 16.1 POINTS REDUCTION OF IMPULSIVITY (P = 0.02; N = 35) AND A SIGNIFICANT 30 ± 50% IMPROVEMENT OF QOL (P = 0.01). AT 12-MFU, 9 PATIENTS STILL WORKED FULL- AND 6 PART-TIME. ADDITIONALLY DOCUMENTED MOTOR AND/OR NEUROPSYCHIATRIC FEATURES DECREASED FROM N = 41 AT BASELINE TO N = 14 AT 12-MFU. CONCLUSION: THE PRESENT STUDY-RESULTS DEMONSTRATE THAT EOPD PATIENTS WITH AND WITHOUT KNOWN GENETIC BACKGROUND BENEFIT FROM STN-DBS WITH SIGNIFICANT IMPROVEMENT IN MOTOR AS WELL AS NON-MOTOR SYMPTOMS. IN LINE WITH THIS, PATIENTS EXPERIENCED A MEANINGFUL REDUCTION OF ADDITIONAL NEUROPSYCHIATRIC FEATURES. PHYSICIANS AS WELL AS PATIENTS HAVE AN UTMOST INTEREST IN POSSIBLE PREDICTORS FOR THE PUTATIVE DBS OUTCOME IN A COHORT WITH SUCH A HIGHLY COMPLEX CLINICAL PROFILE. LONGITUDINAL MONITORING OF DBS-EOPD-PATIENTS OVER LONG-TERM INTERVALS WITH STANDARDIZED COMPREHENSIVE CLINICAL ASSESSMENT, ACCURATE PHENOTYPIC CHARACTERIZATION AND DOCUMENTATION OF CLINICAL OUTCOMES MIGHT HELP TO GAIN INSIGHTS INTO DISEASE ETIOLOGY, TO CONTEXTUALIZE GENOMIC INFORMATION AND TO IDENTIFY PREDICTORS OF OPTIMAL DBS CANDIDATES AS WELL AS THOSE IN DANGER OF DETERIORATION AND/OR NON-RESPONSE IN THE FUTURE. REPORTED EVENTS: 1. ONE PATIENT IMPLANTED WITH BILATERAL STN-DBS EXPERIENCED IMPAIRED WOUND-HEALING IMPROVED UNDER ANTIBIOTICS. 2. ONE PATIENT IMPLANTED WITH BILATERAL STN-DBS EXPERIENCED INTRACRANIAL BLEEDING AROUND ONE ELECTRODE WITH ASSOCIATED APHASIA THAT REMITTED INCOMPLETELY UP TO 12 MONTH FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369282 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Male Required Intervention