BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3627057 · Received February 13, 2014

    Report

    Report Number
    3004209178-2014-02981
    Event Type
    Malfunction
    Date Received
    February 13, 2014
    Report Date
    January 22, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# V011992, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V985676, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURING REPRESENTATIVE REPORTED THAT IMPEDANCES WERE MEASURED AND THEY CONCERNED REGARDING C-5 BEING "???" AND 4-7 BEING GREATER THAN 4,000 OHMS. THE PATIENT'S LEFT SIDE WAS PROGRAMMED TO C+, 2- AT 2.5V, 90 USEC, 140 HZ, WITH A THERAPY IMPEDANCE OF 995 OHMS. THE PATIENT'S RIGHT SIDE WAS PROGRAMMED TO C+, 5- AT 2.7V, 60 USEC, 140 HZ, WITH A THERAPY IMPEDANCE OF 712 OHMS. STIMULATION WAS USED 24 HOURS A DAY AND THE INS WAS ESTIMATED TO REACH END OF SERVICE AT 74 MONTHS. THE CAUSE OF THE HIGH IMPEDANCES WAS NOT DETERMINED. THE PATIENT HAD A HIGH LEVEL OF THERAPY EFFICACY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING/JOLTING SENSATION. IMPEDANCE TESTING WAS PERFORMED WHICH SHOWED HIGH IMPEDANCES AND THE PRINTOUT SHOWED ¿?¿ IN MOST MEASURED READINGS. REPROGRAMMING WAS PERFORMED AND IT WAS NOTED THE NEUROLOGIST WOULD LIKELY HAVE PATIENT RETURN FOR FURTHER TESTING. THE PATIENT ALSO HAD DECREASING SYMPTOMS CONTROL AND A CHANGE IN GAIT. ADDITIONAL INFORMATION RECEIVED ABOUT THREE WEEKS LATER REPORTED THEY WERE WAITING ON THE NEUROLOGY CLINIC TO SCHEDULE AN APPOINTMENT WITH THE PATIENT TO DO FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95107 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR