BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10234306 · Received July 6, 2020

    Report

    Report Number
    3004209178-2020-11613
    Event Type
    Malfunction
    Date Received
    July 6, 2020
    Date of Event
    June 1, 2020
    Report Date
    July 13, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864238
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE CALLER WAS NOTIFIED TODAY THAT 'ABOUT A MONTH AGO' THE CLINICIAN ATTEMPTED TO TURN THE PATIENT'S STIM UP ON THE TABLET AND WAS UNABLE TO GO PAST 4.1. THE CALLER DID NOT KNOW WHAT MESSAGE CAME UP BUT THE CALLER STATES THE PATIENT WAS ABLE TO TURN STIM UP PAST THAT POINT WITH THEIR PROGRAMMER. AN EMAIL WAS SENT TO REPAIR. NO SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED STATING THEY TURNED HAD STIM TO 0.0 MA ON LEFT SIDE BUT SYSTEM WAS STILL SHOWING AS BEING IN OOR. THE CALLER TURNED THE RIGHT SIDE TO 0.0 MA AND SYSTEM REMAINED IN OOR. THE INS WAS AT 75% AND DOING WELL WITH THERAPY. THE CALLER ATTEMPTED TO RUN THERAPY IMPEDANCE (AFTER INCREASING STIM BACK TO 5.2 MA ON BOTH SIDES) BUT RESULTS WERE BLANK AND DIDN'T SHOW ANY VALUES. TECH SERVICES HAD CALLER RUN ELECTRODE IMPEDANCE WHICH GAVE RESULTS BELOW (IN OHMS): LEFT: C-3 1796, C-2 1908, C-1 1146, C-0 1195, 0-1 1674, 0-2 3008, 0-3 2933, 1-3 2834, 1-2 2683, 2-3 3935 RIGHT: C-8 1026, C-9 1076, C-10 1617, C-11 1681, 8-9 1537, 8-10 2437, 8-11 2582, 9-10 2215 9-11 2489, 10-11 2985. THE THERAPY SETTINGS WERE, LEFT: 0- 1+ 5.2 MA, 60 PW 180 RATE RIGHT: 8- 9+ 5.2 MA, 60 PW 180 RATE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER¿S REPRESENTATIVE (REP) REPORTED SEVERAL PROGRAMMERS WERE USED TO TRY AND INCREASE STIMULATION. THE CAUSE OF THE DEVICE NOT GOING ABOVE 4.1 WAS DUE TO THE OUTPUT BEING TOO HIGH IN THE CURRENT MODE. TO RESOLVE THE ISSUE THE REP CHANGED STIMULATION TO VOLTAGE MODE AND MATCHED THE CURRENT OUTPUT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700522 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169864238

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR