BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 22628412 · Received July 28, 2025

    Report

    Report Number
    3004209178-2025-12751
    Event Type
    Malfunction
    Date Received
    July 28, 2025
    Date of Event
    June 24, 2025
    Report Date
    July 28, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000384357
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID: TM90D0, SERIAL# (B)(6), PRODUCT TYPE: ACCESSORY. 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 TM90D0 ACTIVA COMMUNICATOR WAS NOT SYNCING WITH THE IMPLANTED DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATOR (IPG). THE PATIENT REPORTED RECEIVING ERROR CODES 575, 580, 1713, AND 585, AND DESCRIBED THE COMMUNICATOR SCREEN AS BLANK WITH DASHES WHERE NUMBERS SHOULD BE. THE COMMUNICATOR DID NOT RESPOND WHEN ATTEMPTING TO CONNECT, AND ONGOING COMMUNICATOR ISSUES WERE NOTED. THE PATIENT DESCRIBED THE DEVICE AS "FAKE CONNECTING" TO THERAPY, INDICATING THAT THE DEVICE APPEARED CONNECTED BUT THERE WAS NO SYMPTOM RELIEF. THE PATIENT REPORTED BEING IN PAIN AND STATED THAT THERAPY WAS OFF AT ONE POINT, THOUGH IT WAS UNCLEAR IF THERAPY WAS OFF AT THE START OF THE CALL OR TURNED OFF DURING THE CALL. AFTER THERAPY WAS TURNED BACK ON, THE PATIENT DID NOT REPORT A DIFFERENCE IN FEELING. TROUBLESHOOTING STEPS INCLUDED CLOSING ALL APPLICATIONS, RESTARTING THE DEEP BRAIN STIMULATION APPLICATION, AND RECONNECTING TO THE IMPLANT VIA THE APPLICATION. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE, AND A REQUEST WAS SENT TO REPAIR AND REPLACE THE COMMUNICATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694976 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00763000384357

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male