BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK DEEP BRAIN STIMULATOR

    MDR report key: 1913531 · Received November 12, 2010

    Report

    Report Number
    3007566237-2010-09379
    Event Type
    Malfunction
    Date Received
    November 12, 2010
    Report Date
    November 3, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    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

    THE PT EXPERIENCED A FAIRLY SEVERE SHOCKING SENSATION WHEN PUTTING THE TIME RIGHT ON THE CLOCK AND WHEN CHECKING IMPEDANCES AND THERAPY. IMPEDANCE MEASUREMENTS WERE GOOD, REPORTING FOR PROBLEMS. IT WAS NOTED THAT HE HAS FALLEN A NUMBER OF TIMES AND PROBABLY HIT HIS ABDOMEN AND NOT HIS HEAD. HE HAD AN X-RAY FOR PAIN OVER HIS RIBS ON THE RIGHT SIDE. THE PT CAME IN FOR AN URGENT CARE F/U. HE HAD TWO SWALLOW STUDIES WHICH SHOWED HE WAS ASPIRATING. HE WAS REPROGRAMMED REDUCING THE RATE FROM 140 TO 130 AND WAS ABLE TO TALK EASIER. HE WILL HAVE A F/U SWALLOW STUDY. THE DEVICE WAS GIVING HIM THERAPY. HE WILL BE SEEN IN TWO MONTHS OR BEFORE HAND IF HE HAS MORE PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK DEEP BRAIN STIMULATOR MHY MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1