BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2081299 · Received April 21, 2011

    Report

    Report Number
    3004209178-2011-02983
    Event Type
    Malfunction
    Date Received
    April 21, 2011
    Date of Event
    March 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MEDTRONIC 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

    IT WAS REPORTED THAT WHILE STIMULATION WAS TURNED ON, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT WITH DYSTONIC TREMOR AND TORTICOLLIS. THE EVENT OCCURRED FOLLOWING A FALL; THE PATIENT FELL AND HIT HEAD HARD ABOUT (B)(6) AGO. THE PATIENT WAS BACK TO BASELINE SINCE THEN. THE LOCATION OF THE SYMPTOMS WAS THE HEAD AND NECK. IMPEDANCE MEASUREMENTS WERE NORMAL; 500-900 OHMS FOR ALL UNIPOLAR AND BIPOLAR PAIRS. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU187334V| PROGRAMMER: MODEL 7436, LOT# NFU023330P| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3387S, LOT# V165754| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482A, LOT# NHU187335V| IMPLANTED:| LEAD: MODEL 3387S, LOT# V165754| IMPLANTED: