BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8768173 · Received July 8, 2019

    Report

    Report Number
    3004209178-2019-13070
    Event Type
    Malfunction
    Date Received
    July 8, 2019
    Date of Event
    May 14, 2019
    Report Date
    July 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    UDI-DI
    00613994934611
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN DEVICE IS NOT APPROVED UNDER PMA/510K # H020007 FOR THE DESCRIBED INDICATION: DYSTONIA (PRODUCT CODE: MRU). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER, VIA A MANUFACTURING REPRESENTATIVE (REP), REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THAT AN OUT OF REGULATION (OOR) MESSAGE WAS ON THEIR PATIENT PROGRAMMER (PP) IN MAY AND AGAIN YESTERDAY. THE CAREGIVER INDICATED THAT EVERY ONCE IN A WHILE THEY HAVE EPISODES OF RIGIDITY AND THEY HAD ONE ABOUT A MONTH AGO. THE INS WAS CHARGED AT 100%, THE PATIENT USES THE PATIENT PROGRAMMER (PP) AND DOES HAVE HIGH SETTINGS (VOLTAGE MODE) IMPEDANCES WERE CHECKED: LEFT GPI: C-0 1760, C-1 5355, C-2 3891, C-3 4836; 0-1 3992, 0-2 3334, 0-3 4170; 1-2 4262, 1-3 5940; 2-3 2407; RIGHT GPI: C-4 2378, C-5 508, C-6 686, C-7 951. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562941 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00613994934611

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR