BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN NEUROSTIMULATOR

    MDR report key: 3221693 · Received July 11, 2013

    Report

    Report Number
    3007566237-2013-02317
    Event Type
    Malfunction
    Date Received
    July 11, 2013
    Date of Event
    June 21, 2013
    Report Date
    June 21, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013: PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2013: PRODUCT TYPE EXTENSION; PRODUCT ID 3387S-40, LOT# VA03X0T, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT# VA02S0T, IMPLANTED: (B)(6) 2012: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCE READINGS WERE OBSERVED. IT WAS FURTHER REPORTED THAT INTRA-OPERATIVE IMPEDANCES ASSOCIATED WITH CONTACT 0 WERE ¿14000 OHMS¿ AND 30 MINUTES POST-OPERATIVE THEY WERE ¿21000 OHMS.¿ IT WAS NOTED THAT CONTACT 0 WAS ON THE LEFT LEAD AND WAS ¿PROGRAMMED WITH THE CASE+ TO 5.9 VOLTS¿ AT THE TIME OF REPORT. IT WAS ALSO NOTED THE PATIENT HAD ¿CONTROL OF HER RIGHT HAND TREMOR¿ AND ¿RESPONDED WELL¿ AT THE TIME OF REPORT. IT WAS STATED THAT IMPEDANCE MEASUREMENTS WOULD BE ¿RE-RUN¿ AND THE PATIENT WOULD BE REPROGRAMMED IF NEEDED. ADDITIONAL INFORMATION STATED THE THIRD IMPEDANCE TEST REPORTED THAT ¿VALUES FOR CONTACT 0 ON THE LEFT LEAD WERE BETWEEN 6000-7000 OHMS.¿ IT WAS NOTED THIS WAS A ¿SIGNIFICANT REDUCTION.¿ IT WAS ALSO NOTED ¿THE PATIENT WAS GETTING THERAPY ON HER RIGHT SIDE.¿ ADDITIONAL INFORMATION STATED THE THIRD IMPEDANCE TEST OCCURRED ¿AN HOUR PAST SURGERY¿ AND FOUND ¿ALL OTHER CONTACTS WERE IN THE NORMAL RANGE FOR MONOPOLAR SETTINGS.¿ IT WAS NOTED THAT IMPEDANCE VALUES WERE WITHIN NORMAL RANGE PRIOR TO THE EXPLANT PROCEDURE. IT WAS REPORTED THAT AT THE TIME OF THE THIRD IMPEDANCE MEASUREMENT, THE PATIENT WAS ¿FEELING FINE AND RECEIVING EFFECTIVE THERAPY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319570 UNKNOWN NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR