BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 22320951 · Received June 24, 2025

    Report

    Report Number
    2182207-2025-01631
    Event Type
    Injury
    Date Received
    June 24, 2025
    Date of Event
    April 8, 2025
    Report Date
    June 24, 2025
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR (LOT: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE BRAND NAME IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR (LOT: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE BRAND NAME IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR (LOT: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE BRAND NAME IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR (LOT: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE BRAND NAME IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR (LOT: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE WANG, X., WANG, J., LI, N., WEN, Y., WANG, B., KOU, H., FU, J., QU, H., QIU, C., JING, Z., SU, M., ZHENG, Z., WANG, X., QU, Y.. DEEP BRAIN STIMULATION IN PARKINSON'S DISEASE PATIENTS OVER 75 YEARS OF AGE: A SINGLE-INSTITUTION RETROSPECTIVE ANALYSIS. CNS NEUROSCIENCE THERAPEUTICS 31 2025. 10.1111/CNS.70397 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 IN PARKINSON'S DISEASE PATIENTS OVER 75 YEARS OF AGE: A SINGLE-INSTITUTION RETROSPECTIVE ANALYSIS.¿ THE FOLLOWING MEDTRONIC DEVICES WERE USED: 3389 AND 3387 ELECTRODES. AMONG ALL PATIENTS, ADVERSE EVENTS INCLUDED: TWO PATIENTS HAD INTRACRANIAL HEMORRHAGE DURING SURGERY. ONE PATIENT HAD AN INTRAOPERATIVE SEIZURE. ONE PATIENT DEVELOPED WOUND INFECTION. ONE PATIENT HAD A SYSTEM REMOVAL. TWO PATIENTS EXPERIENCED TRANSIENT CONSCIOUSNESS DISORDER (LOSS OF CONSCIOUSNESS). TWENTY PATIENTS EXPERIENCED TRANSIENT PSYCHIATRIC DETERIORATION (INCLUDING DELIRIUM AND CONFUSION). NO FURTHER INFORMATION WAS PROVIDED PERTAINING TO MEDTRONIC PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1999243 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention SEE H11...