BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 23468659 · Received November 4, 2025

    Report

    Report Number
    2182207-2025-03016
    Event Type
    Injury
    Date Received
    November 4, 2025
    Date of Event
    August 1, 2025
    Report Date
    November 4, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    WANG, S., HU, W., GAO, Y., WANG, A., CHEN, L., LIANG, Z., ZHANG, S., LONG, H., LI, W., NIU, C., LIU, W., CAI, G., JI, Y., TAM, J., XU, Q., YANG, A., SHI, L., ZHANG, H., HAN, C., ¿ ZHANG, J. (2025). DEEP BRAIN STIMULATION SURGICAL TIMING, OUTCOMES, AND PROGNOSTIC FACTORS IN PATIENTS WITH PARKINSON'S DISEASE: A CHINESE RETROSPECTIVE MULTICENTER COHORT STUDY. PLOS MEDICINE, 22(8). HTTPS://DOI.ORG /10.1371/JOURNAL.PMED.1004670 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 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

    LITERATURE WAS REVIEWED REGARDING ¿DEEP BRAIN STIMULATION SURGICAL TIMING, OUTCOMES, AND PROGNOSTIC FACTORS IN PATIENTS WITH PARKINSON¿S DISEASE: A CHINESE RETROSPECTIVE MULTICENTER COHORT STUDY.¿ MULTIPLE MANUFACTURERS¿ DEVICES WERE IMPLANTED IN THE STUDY POPULATION. THE FOLLOWING MEDTRONIC DEVICES WERE USED: 37612 ACTIVA RC IMPLANTABLE PULSE GENERATORS. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: 35 PATIENTS DEVELOPED INFECTION, WHICH RESOLVED WITH DRESSING CHANGES AND ANTIBIOTICS. NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744487 ACTIVA Stimulator, electrical, implanted, for parkinsonian tremor MHY MEDTRONIC NEUROMODULATION 37612 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male Required Intervention