BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3530567 · Received December 20, 2013

    Report

    Report Number
    3004209178-2013-23827
    Event Type
    Malfunction
    Date Received
    December 20, 2013
    Date of Event
    November 21, 2013
    Report Date
    November 24, 2013
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V091127, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V091127, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO ADJUST STIMULATION. IT WAS NOTED THAT THE PATIENT PROGRAMMER BEEPED WHEN SHE TRIED TO INCREASE OR DECREASE THE STIMULATION. THE REPORTER STATED THAT THE PATIENT WAS IN THE HOSPITAL BUT HAD TURNED OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) WHEN THE PATIENT HAD MEDICAL PROCEDURES SUCH AS ¿KEG.¿ IT WAS NOTED THAT THE PATIENT WAS GETTING AN ULTRASOUND AND WAS NOT AVAILABLE AT THE TIME OF REPORT. IT WAS NOTED THAT THE PATIENT WAS IN THE HOSPITAL BECAUSE THEY WERE GOING TO REPLACE THE STIMULATOR BATTERY LAST TUESDAY BUT WHEN THEY DID THE PRE-ADMISSION TESTING THE WEDNESDAY BEFORE THEY FOUND THAT HIS KIDNEY FUNCTION WAS REAL LOW AND HIS BLOOD PRESSURE WAS REAL LOW. IT WAS NOTED THAT THEY HAD TO SHOCK THE PATIENT¿S HEART TO GET HIM BACK IN RHYTHM. IT WAS NOTED THAT THE PATIENT WAS GROGGY LIKE HE WAS UNDER ANESTHESIA BUT THAT THEY HADN¿T GIVEN HIM ANYTHING SINCE THURSDAY MORNING WHEN THEY DID HIS HEART SHOCK. IT WAS NOTED THAT THE INS WAS TURNED OFF DURING ALL OF THE TESTS INCLUDING THE HEART SHOCK. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GROGGIER. IT WAS NOTED THAT LAST THURSDAY THE PATIENT HAD A CARDIO VERSION AND IT ZAPPED THE HEART AND MAY HAVE MESSED UP THE BASE LINE OF THE INS. IT WAS NOTED THAT SINCE THURSDAY THE PATIENT WAS FEELING GROGGY. IT WAS NOTED THAT THE REPORTER USED THE PATIENT PROGRAMMER TO TURN STIMULATION UP OR DOWN ON THE INS. IT WAS NOTED THAT THE REPORTER WOULD LIKE TO MEET WITH A MANUFACTURING REPRESENTATIVE TO GET THE DEVICE CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669785 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR