BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5135412 · Received October 8, 2015

    Report

    Report Number
    3004209178-2015-20201
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Report Date
    September 16, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V779204, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) REPORTED THAT IMPEDANCES HAD BEEN TAKEN AT AN APPOINTMENT THE DAY OF THIS REPORT. THE PATIENT WAS STILL GETTING GOOD THERAPY BUT SHE WANTED TO KNOW IF THE IMPEDANCES WERE CAUSE FOR CONCERN. THE THERAPY IMPEDANCE MEASURED IN (B)(6) 2015 WAS 2960 OHMS. ON THE DAY OF THIS REPORT, IT MEASURED 4483 OHMS. THE PATIENT WAS PROGRAMMED AT C+3-, AN AMPLITUDE OF 3.5 VOLTS, A PULSE WIDTH OF 120 MICROSECONDS, AND A RATE OF 185 HERTZ. IMPEDANCES WERE TAKEN THE DAY OF THIS REPORT AT 3.0 VOLTS. THEY WERE AS FOLLOWS: C0=1414 OHMS, C1=786 OHMS, C2=1777 OHMS, C3=786 OHMS, 01=1703 OHMS, 02=3155 OHMS, 03=1712 OHMS, 12=1938 OHMS, 13=184 OHMS, AND 23=1856 OHMS. FROM JULY AT 0.7 VOLTS, ALL BIPOLE PAIRS WERE SIMILAR TO PAIR 13 WHICH HAD BEEN AT 2360 OHMS. A MOTOR VEHICLE ACCIDENT WAS NOTED TO BE POSSIBLY RELATED. A COUPLE OF FALLS HAD OCCURRED WITHIN THE LAST 3 MONTHS. DURING ONE OF THE FALLS, THE PATIENT HIT THE BACK OF HIS HEAD. ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE 13 IMPEDANCE, WHICH HAD BEEN 184 OHMS ON THE DAY OF THIS REPORT, WAS MEASURED TO BE 1981 OHMS ON (B)(6) 2015. C+3- WAS BEING USED FOR THERAPY TO RESOLVE THIS ISSUE. THE IMPEDANCE FOR THIS WAS NOTED TO BE 786 OHMS. THE CAUSE OF THE FALL WAS UNKNOWN; THE PATIENT HAD STATED THAT HE FELL BACKWARDS AND THIS WAS NO TED TO BE COMMON WITH PARKINSON'S DISEASE. RELEVANT MEDICAL HISTORY INCLUDED PARKINSONS DUAL AND MOVEMENT DISORDERS. NO FURTHER FOLLOW-UP WAS REQUIRED. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669663 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603

    Patients

    Seq Age Sex Outcome Treatment
    1