BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7156735 · Received January 2, 2018

    Report

    Report Number
    3004209178-2018-00018
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Date of Event
    December 27, 2017
    Report Date
    February 28, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT WASN'T RECEIVING THERAPY ON THEIR RIGHT BODY. AN IMPEDANCE CHECK WAS PERFORMED, C AND 0 11902; 0 AND 1 15235, 0 AND 2 12620, AND 0 AND 3 15688. THEIR SETTINGS WERE PROGRAMMED C+ 0- 3V 60 PW 180 RATE. NO CONTRIBUTING FACTORS WERE KNOWN, NO TROUBLESHOOTING WAS DONE, AND NO INTERVENTIONS WERE TAKEN. THE ISSUE WAS NOT RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURING REPRESENTATIVE (REP) INDICATING THE CAUSE HAD NOT BEEN DETERMINED. THE HCP REMAPPED THE PATIENT AND WAS USING A DIFFERENT CONFIGURATION, ELIMINATING CONTACT 0. CONTACT 0 WAS STILL HIGH HOWEVER THE PATIENT WAS DOING WELL ON THE NEW SETTINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR