BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 19135491 · Received April 18, 2024

    Report

    Report Number
    3004209178-2024-09339
    Event Type
    Injury
    Date Received
    April 18, 2024
    Report Date
    April 18, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864238
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    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

    IT WAS REPORTED THAT THE PATIENT, DUE TO THE PROGRESSION OF THE DISEASE, SINCE ABOUT 2017-2018 CAN'T MAKE ANYMORE ADJUSTMENTS TO HELP THE PATIENT BUT DBS HELPS PATIENT MOVE. IF INCREASING, IT CAN MAKE PATIENT FEEL SICK, PASS OUT, SLEEP OR IS TOO STRONG IT ZINGS HIM WHEN THEY TRY TO ADJUST THE SETTINGS. PATIENT STATES THEY HAVE TRIED ALL DIFFERENT FORMULAS AND HAVE NOT BEEN ABLE TO MAKE ANY ADJUSTMENTS FOR YEARS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270617 ACTIVA Stimulator, electrical, implanted, for parkinsonian tremor MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169864238

    Patients

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