BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 20990037 · Received December 20, 2024

    Report

    Report Number
    2182207-2024-04953
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    November 4, 2024
    Report Date
    December 20, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3387 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID 3387 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: 3387, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3387, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: THE EFFECT OF PALLIDAL STIMULATION ON SLEEP OUTCOMES AND RELATED BRAIN CONNECTOMETRIES IN PARKINSON¿S DISEASE. ZHENG, Z., LIU, D., FAN, H., XIE, H., ZHANG, Q., QIN, G., JIANG, Y., MENG, F., YIN, Z., YANG, A., ZHANG, J. NPJ PARKINSON¿S DISEASE / (2024) 10:212. DOI: 10.1038/S41531-024-00800-4. 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 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

    THE EFFECT OF PALLIDAL STIMULATION ON SLEEP OUTCOMES AND RELATED BRAIN CONFECTIONERIES IN PARKINSON¿S DISEASE. ZHENG, Z., LIU, D., FAN, H., XIE, H., ZHANG, Q., QIN, G., JIANG, Y., MENG, F., YIN, Z., YANG, A., ZHANG, J. NPJ PARKINSON¿S DISEASE / (2024) 10:212. DOI: 10.1038/S41531-024-00800-4. SUMMARY: SLEEP DIFFICULTIES AFFECT UP TO 98% OF PARKINSON¿S DISEASE (PD) PATIENTS AND ARE OFTEN NOT WELL TREATED. HOW GLOBUS PALLIDUS INTERNUS (GPI)-DBS COULD HELP IS LESS UNDERSTOOD. WE RETROSPECTIVELY ANALYZED SLEEP OUTCOMES IN 32 PD PATIENTS AFTER GPI-DBS WITH A TWO-YEAR FOLLOW-UP. WE OBSERVED HIGH HETEROGENEITY IN SLEEP RESPONSE TO PALLIDAL STIMULATION: 16 PATIENTS SHOWED CLINICALLY MEANINGFUL IMPROVEMENT, 9 HAD MINOR CHANGES, AND 7 EXPERIENCED WORSENED SLEEP QUALITY, WITH NO OVERALL SIGNIFICANT CHANGE ON THE PARKINSON¿S DISEASE SLEEP SCALE-2 (P = 0.19). FURTHER ANALYSIS REVEALED THAT STIMULATION OF THE LEFT SENSORIMOTOR GPI WAS SIGNIFICANTLY ASSOCIATED WITH SLEEP IMPROVEMENT. FIBER TRACTS FROM THE LEFT SENSORIMOTOR GPI TO THE BILATERAL SENSORIMOTOR CORTEX, RIGHT GPI, BRAINSTEM, AND BILATERAL CEREBELLUM WERE LINKED TO BETTER SLEEP, WHILE PROJECTIONS TO THE LEFT HIPPOCAMPUS CORRELATED WITH WORSENED SLEEP. THESE FINDINGS MAY GUIDE PERSONALIZED GPI-DBS LEAD PLACEMENT TO OPTIMIZE SLEEP OUTCOMES IN PD. REPORTED EVENTS: 1. IT WAS REPORTED THAT SEVEN PATIENT'S WHO UNDERWENT BILATERAL GPI-DBS EXPERIENCED EXPERIENCED WORSENING SLEEP. THESE PATIENT'S ALSO EXPERIENCED WORSENING RAPID EYE MOVEMENT BEHAVIOR DISORDER. THOSE WITH WORSENED SLEEP HAD ONLY A SIGNIFICANT WORSENING OF PD SYMPTOMS AT NIGHT, WHICH CONTAINED NOCTURNAL HALLUCINATIONS, DIFFICULTY IN TURNING AROUND, PAIN IN THE EXTREMITIES, MUSCLE CRAMP, AND SNORING OR BREATHING PROBLEMS. SPECIFICALLY, ONLY ONE PATIENT HAD HALLUCINATIONS AT NIGHT, WHILE OTHERS HAD WORSENED TURNING OVER PROBLEMS, PAIN, AND MUSCLE CRAMPS. TURNING OVER REQUIRES THE USE OF THE MUSCLE OF THE CENTRAL AXIS. WORSENING AXIAL SYMPTOMS HAS BEEN REPORTED FREQUENTLY IN LARGE DBS TRIALS AS AN ADVERSE EFFECT AFTER HIGH FREQUENCY STIMULATION. 2. IT WAS REPORTED THAT THREE PATIENT'S WHO UNDERWENT BILATERAL GPI-DBS EXPERIENCED SEVERE COGNITIVE OR PSYCHOLOGICAL DISORDER. 3. IT WAS REPORTED THAT ONE PATIENT WHO UNDERWENT BILATERAL GPI-DBS EXPERIENCED SEVERE ADVERSE EFFECT OF DBS. 4. IT WAS REPORTED THAT ONE PATIENT WHO UNDERWENT BILATERAL GPI-DBS EXPERIENCED OTHER NEURODEGENERATIVE DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2151577 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Other "SEE H11...."