BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 10380294 · Received August 7, 2020

    Report

    Report Number
    3004209178-2020-13674
    Event Type
    Malfunction
    Date Received
    August 7, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 7, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00763000100346
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT SAW OUT OF REGULATION (OOR) ON THEIR PATIENT PROGRAMMER (PP) TWO DAYS AGO, THUS THE HEALTHCARE PROVIDER (HCP) GOT THE PATIENT TO COME INTO THE OFFICE TO CHECK IMPEDANCES. THE PATIENT WAS PROGRAMMED C, 1-, 2-. THE HCP DOES NOT RECALL SEEING OOR ON THE TABLET TODAY DURING INTERROGATION. POTENTIAL FOR SHORT WAS DISCUSSED, EVEN THOUGHIT'S NOT APPARENT AT THIS POINT, HOWEVER 1<(>&<)>2 AND 2<(>&<)>3 ARE AT 693 OHMS FOR BOTH BIPOLES. THE HCP SAID THEY MIGHT TRY C AND 2 FOR PROGRAMMING. THEY SWITCHED THE PATIENT TO 2+0- TODAY BEFORE THEY RAN THE THERAPY IMPEDANCE. THEY ARE NOT GETTING THERAPY IMPEDANCE VALUES, BUT RATHER, WHERE IMPEDANCE AND CURRENT VALUES SHOULD BE. ELECTRODE IMPEDANCES SHOWED: 3 572 OHMS 2 835 1 572 0 1501 03 1411 02 1821 01 1408 13 LOW 12 693 2<(>&<)>3 693 OHMS THEY EXITED THE SESSION, RE-INTERROGATED, AND RAN THERAPY IMPEDANCE AGAIN. THIS TIME, THEY GOT VALUES. THE IMPEDANCE IS STILL SIMILAR. POTENTIAL ISSUE WITH IMPEDANCE SINCE BIPOLE OF 1<(>&<)>2 AND 2<(>&<)>3 ARE EXACTLY THE SAME. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844659 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602 00763000100346

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR