BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6650412 · Received June 19, 2017

    Report

    Report Number
    3004209178-2017-13176
    Event Type
    Malfunction
    Date Received
    June 19, 2017
    Date of Event
    June 14, 2017
    Report Date
    July 12, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    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

    A MANUFACTURER REPRESENTATIVE (REP) AND A PATIENT IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR PARKINSON'S DUAL AND MOVEMENT DISORDERS REPORTED THAT THE PATIENT LOST SYMPTOM CONTROL AN HOUR AFTER THEIR LAST ADJUSTMENT. THE PATIENT¿S SYMPTOMS ARE NORMALLY CONTROLLED WITH STIMULATION, BUT THEY HAVE HAD FESTINATION OF GAIT AND BALANCE ISSUES WHICH CAUSED SOME FALLS. IMPEDANCES WERE WITHIN NORMAL LIMITS. A WEEK PRIOR TO THIS REPORT, THE PATIENT¿S MEDICATIONS WAS CHANGED FROM REGULAR SINEMET TO RYTARY. THE PATIENT WAS ALSO REFERRED TO PHYSICAL THERAPY FOR BALANCE TRAINING. ON THE DAY OF THIS REPORT, THE PATIENT¿S PHYSICAL THERAPIST NOTICED THEY WERE DOING WORSE THAN THEY HAD SEEN. THE PATIENT WAS SENT TO SEE THEIR PHYSICIAN. THE DEVICE WAS CHECKED AND IT WAS CONFIRMED THAT IT WAS ON AND FUNCTIONING. THE PATIENT WAS UNABLE TO AMBULATE WITHOUT FESTINATING OR FALLING AND HAD TO USE A WHEEL CHAIR TO GET AROUND. THE PHYSICIAN SWITCHED THE PATIENT FROM RYTARY BACK TO SINEMET AT THE ORIGINAL DOSE PRIOR TO DEEP BRAIN STIMULATION (DBS). THE DEVICE WAS TURNED OFF UNTIL THE PATIENT¿S MEDICATIONS ARE LEVELED OUT AND MORE ON/OFF TESTING CAN BE DONE. THE PATIENT WAS TENTATIVELY SCHEDULED FOR ON/OFF TESTING AND POSSIBLE MRI TO CHECK LEAD PLACEMENT ON (B)(6). NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS REMAPPED AND A MORE PROXIMAL CONTACT WAS CHOSEN. THE REPORTED SYMPTOMS HAVE IMPROVED SINCE THE CHANGE IN PROGRAMMING AND HAS BEEN SUSTAINED FOR A COUPLE OF WEEKS AT THE TIME OF THIS REPORT. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430091 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR