BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCEPT

    MDR report key: 12822908 · Received November 16, 2021

    Report

    Report Number
    2182207-2021-02007
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 16, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER SETTING ADAPTIVE DEEP BRAIN STIMULATION (ADBS), THE PATIENT'S CONDITION DETERIORATED. WHEN DEVICE WAS INT ERROGATED, ALL OF THE TIME LINES TURNED STIMULATION OFF. THE STIMULATION APPEARED TO BE ON AT THE MOMENT OF TELEMETRY, AND ADBS FUNCTIONED WHEN COMMUNICATION WAS MADE. IN THE DOCTOR'S OPINION, IT SEEMED THE STIMULATION WAS TURNED TO OFF WHEN COMMUNICATION WAS CANC ELED; THE PATIENT'S CONDITION WAS THE SAME. THE CAUSE WAS THOUGHT TO BE RELATED TO RECENT UPDATE OF THE DBS CLINICIAN APPLICATION. ADDITIONAL INFORMATION REPORTED THAT THERE WAS MISSING DATA FOR THE SESSION A ON (B)(6) 2021 AT 8:49AM. THE VIEW SHOWED 2 PINK EVENT MARKS AND 3 LFP TREND DATA POINTS BEFORE 8PM PROGRAMMING SESSION AND LFP TREND DATA POINTS AFTER 10PM. FOR THIS CASE SINCE THE PATIENT HAD BEEN PROGRAMMED WITH EITHER PASSIVE OR ADAPTIVE SETTING, THEY WOULD EXPECT THERE ARE DATA FOR LFP TREND IF READ ALL EVENTS WERE PRESSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718695 PERCEPT STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION B35200

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown