BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1923266 · Received November 9, 2010

    Report

    Report Number
    3004209178-2010-09109
    Event Type
    Malfunction
    Date Received
    November 9, 2010
    Date of Event
    September 1, 2010
    Report Date
    October 19, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A MANUFACTURER'S REPRESENTATIVE MEASURED ">4000 OHMS" ON SOME OF THE PT'S BIPOLAR PAIRS, SPECIFICALLY PAIRS 4,6 AND 4,7. THE PT WAS ORIGINALLY PROGRAMMED TO C,5 BUT WAS SWITCHED TO C,6 BECAUSE OF HIS SPEECH PROBLEMS. THE PT FELL ON HIS CHEST "ABOUT A MONTH AGO" AND NOW "WHEN HE PRESSES ON THE HEADER BLOCK OF INS HE GET FACIAL STIMULATION INTERMITTENTLY." A GROUP IMPEDANCE TEST WAS PERFORMED AND THE PT EXPERIENCED FACIAL STIMULATION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR LEAD: MODEL 3387S, LOT# V065399| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU169652V| EXPLANTED:| LEAD: MODEL 3387S, LOT# V067508| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 8472A51, LOT# NHU169636V