BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1872199 · Received October 14, 2010

    Report

    Report Number
    3004209178-2010-07937
    Event Type
    Malfunction
    Date Received
    October 14, 2010
    Date of Event
    September 16, 2010
    Report Date
    September 16, 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
    NH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PT'S SYMPTOMS RETURNED ON (B)(6) 2010 AT APPROXIMATELY 4:00 AM WHILE USING AN EXTERNAL BONE GROWTH STIMULATOR. IT WAS RECOMMENDED THAT THE PT WAS TO STOP USING THE DEVICE. THE PT HAD TREMORS WHICH LATER RESOLVED, IN ADDITION TO DIFFICULTY IN FORMING WORDS WHICH WAS ONGOING. IT WAS NOTED THAT THE PT'S DEVICE HAD UNEXPECTEDLY TURNED OFF WHILE HE WAS A PASSENGER IN A VEHICLE, HOWEVER, THIS ISSUE WAS RESOLVED BY TURNING THE DEVICE BACK ON AGAIN. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO IS BEING REQUESTED FROM THE HCP, AND WILL BE PROVIDED IN A FOLLOW-UP REPORT AS IT 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 72 YR EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V055961| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V055961| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU161216V| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT# NHU161215V| PROGRAMMER: MODEL 7436, LOT# NFU017227P