BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4480367 · Received February 3, 2015

    Report

    Report Number
    3004209178-2015-01621
    Event Type
    Malfunction
    Date Received
    February 3, 2015
    Report Date
    January 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V680690, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 3387S-40, LOT# V626366, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE: EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT# VA0LLN7, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3387S-40, LOT# VA0K84F, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION; PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37612, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS HAVING EXCELLENT BENEFIT AS FAR AS THEIR TREMOR WAS CONCERNED. IT HAD APPEARED THAT THE CONTACT THAT THE PATIENT WAS PROGRAMMED TO ON THE RIGHT SIDE, 8-11 WAS SHORTED OR AT LEAST WAS VERY LOW. PATIENT¿S SETTINGS ON THE LEFT WERE 3+1-, 3.9V, 90USEC, 230 HZ AND 1500 OHMS. ON THE RIGHT THEY WERE 11+8-, 3.9V, 90USEC, 230HZ AND 125 OHMS. ELECTRODE IMPEDANCES WERE C/0-1729, C/1-986, C/2-1549, C/3-992, 0/1-1855, 0/2-2808, 0/3-2237, 1/2-1806, 1/3-1500, 2/3-1711, C/8-1380, C/9-2583, C/10-2962, C/11-1392, 8/9-2889, 8/10-3932, 8/11-125, 9/10-5289, 9/11-2913, 10/11-3910. NO INTERVENTION OR OUTCOME WAS REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78394 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR