BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 1885174 · Received October 25, 2010

    Report

    Report Number
    3004209178-2010-08374
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    November 1, 2010
    Report Date
    October 2, 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
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    INFO RECEIVED REPORTS WITH STIMULATION TURNED ON THE PT EXPERIENCED DIFFICULTY SPEAKING AND SWALLOWING. HE WAS SEEN IN THE EMERGENCY ROOM AND THE MAGNET WAS USED TO VERIFY THE DEVICE WAS ON. THERAPY WAS NOT TURNED OFF BUT PT DID UNDER GO A CAT SCAN TO RULE OUT A STROKE. IT WAS ALSO NOTED THAT THE PT HAD HIGH BLOOD PRESSURE READINGS (180/105) AND HE DOES NOT USUALLY RUN HIGH. THE MORNING AFTER THE ER VISIT, THE PT WAS ABLE TO TALK WITH HIS SPOUSE. SEVERAL DAYS LATER AT THE FOLLOW UP VISIT WITH THE PT'S PHYSICIAN AND A MEDTRONIC REP INTERROGATION OF THE DEVICE REVEALED IMPEDANCES >4000 OHMS ON ALL OF THE BIPOLAR PAIRS. CONTACTS 4-7 >4000 AND <15 MA ON ALL BIPOLAR PAIRS. PT WAS NOW REPORTING A LOSS OF THERAPEUTIC EFFECT ON THE LEFT SIDE OF HIS BODY. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    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 68 YR EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A51,LOT # NHU205378V| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT # NHU199455V| LEAD: MODEL 3387, LOT# V255260| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT#: V281324| EXPLANTED: