BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 20916383 · Received December 12, 2024

    Report

    Report Number
    2182207-2024-04853
    Event Type
    Malfunction
    Date Received
    December 12, 2024
    Date of Event
    October 24, 2024
    Report Date
    December 12, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN/UNKNOWN. PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN/UNKNOWN. A2. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3. THIS VALUE REFLECTS THE SEX OR GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CITATION: SANMARTINO F, CANO-CANO F, RASHID-LÓPEZ R, ET AL. SIGNIFICANCE OF NEURODEGENERATION AND NEUROPLASTICITY SERUM BIOMARKERS IN PARKINSON¿S DISEASE PATIENTS TREATED WITH SUBTHALAMIC STIMULATION. NPJ PARK¿S DIS. 2024;10(1):197. DOI:10.1038/S41531-024-00808-W. 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 "SIGNIFICANCE OF NEURODEGENERATION AND NEUROPLASTICITY SERUM BIOMARKERS IN PARKINSON¿S DISEASE PATIENTS TREATED WITH SUBTHALAMIC STIMULATION". THE FOLLOWING MEDTRONIC DEVICES WERE USED: 3389 LEAD REPORTED EVENTS: PARTICIPANTS WERE EXCLUDED FROM THE STUDY IF THEY MET ANY OF THE FOLLOWING CRITERIA:  (I) SEVERE OR MODERATE COGNITIVE IMPAIRMENT COMPARABLE TO DEMENTIA, AS REVEALED BY A MINI-MENTAL PARKINSON (MMP) SCORE <(><<)> 24;  (II) ANY INCAPACITATING PSYCHIATRIC CONDITION;  (III) A HISTORY OF DRUG OR ALCOHOL ABUSE OR IMPULSE CONTROL DISORDER;  (IV) THE PRESENCE OF A SERIOUS SYSTEMIC DISEASE, OTHER NEUROLOGIC DISORDERS, OR MEDICAL CONDITIONS;  (V) ATYPICAL PARKINSONISM OR NEUROLOGICAL COMORBIDITIES; (VI) RECENT TRAUMATIC EVENTS, ACUTE FEVER, OR NEUROINFLAMMATION; AND (VII) DBS SURGICAL COMPLICATIONS, SUCH AS HEMORRHAGE, INFECTION, PERIELECTRODE EDEMA, BREAKING DBS LEADS OR WIRES, ELECTRODE IMPEDANCE, AND HARDWARE-RELATED ISSUES.  IN THE PD-NDBS GROUP, ONE PATIENT¿S DBS TREATMENT WAS INTERRUPTED DUE TO LEAD WIRE BREAKAGE, SO THEY WERE NOT ABLE TO BE EXAMINED AT THE ONE-YEAR FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155428 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male "SEE H11...."