BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 3243285 · Received July 23, 2013

    Report

    Report Number
    3004209178-2013-12187
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Report Date
    March 25, 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
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V042082, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V045101, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD ¿VERY STRANGE¿ IMPEDANCES THE WEEK PRIOR TO THE REPORT. THE REPORTER STATED THAT THE PATIENT WAS GETTING THERAPY AND HIS SYMPTOMS WOULD INCREASE IF THERAPY WAS TURNED OFF. IT WAS REPORTED THAT THE PATIENT APPEARED ASYMPTOMATIC WHEN SEEN BY A HEALTHCARE PROVIDER (HCP). IT WAS NOTED THAT THE IMPEDANCES WERE RUN AT A DEFAULT SETTING AS USUAL ON THE RIGHT SIDE AND ALL WERE 690 OHMS AND THE CURRENT WAS LESS THAN 15 AMPS. THE REPORTER STATED THAT WHEN THERAPY IMPEDANCE WAS TESTED, THERE WAS A MESSAGE THAT IT WOULD NOT BE DONE BECAUSE "ELECTRODES WERE OFF AND THEY WERE DISCONNECTED." IT WAS REPORTED THAT THE PATIENT HAD A FALL TWO WEEKS PRIOR TO THE REPORT AND HIT HIS HEAD REALLY HARD. IT WAS NOTED THAT THE CLINICIAN PROGRAMMER SHOWED QUESTION MARKS IN THE THERAPY MEASUREMENT SECTION WHEN THE THERAPY IMPEDANCE MEASUREMENT INFORMATION WAS ACCESSED ON THE DAY OF THE REPORT, SEVERAL DAYS AFTER THE MEASUREMENTS WERE TAKEN WITH THE PATIENT. NO ELECTRODE IMPEDANCES WERE SEEN IN THE PRINT-OUT FROM THE CLINICIAN PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342850 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR