BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3242951 · Received July 23, 2013

    Report

    Report Number
    3007566237-2013-02451
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    January 4, 2011
    Report Date
    August 11, 2011
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT PRODUCTS: PRODUCT ID 3389, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389S-40, LOT# V126339, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V130326, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD; PRODUCT ID 748240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION; PRODUCT ID 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. CORRECTION: MANUFACTURING SITE ID SHOULD BE (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADAMS, C., KEEP, M., MARTIN, K., MCVICKER, J., KUMAR, R. ACUTE INDUCTION OF LEVODOPA-RESISTANT FREEZING OF GAIT UPON SUBTHALAMIC NUCLEUS ELECTRODE IMPLANTATION. PARKINSONISM AND RELATED DISORDERS. 2011;17(6):488-490. SUMMARY: FREEZING OF GAIT (FOG) IS DEFINED AS AN EPISODIC MOMENTARY INABILITY TO WALK ASSOCIATED WITH PARKINSONISM OR HIGH-LEVEL GAIT DISORDERS. IT OCCURS DURING DISTRACTION, INITIATION, TURNS, SPATIAL LIMITATIONS, AND STRESS. A PATIENT CAN EITHER HAVE LEVODOPA (L -DOPA)-RESPONSIVE FOG (OFF FOG), WHICH APPEARS WHEN THE L-DOPA EFFECT WEARS OFF OR, ESPECIALLY IN ADVANCED PARKINSON¿S DISEASE (PD), A PATIENT MAY HAVE L-DOPA-RESISTANT FOG (ON FOG) DESPITE BENEFIT FROM L-DOPA ON OTHER PARKINSONIAN FEATURES. THE PATHOPHYSIOLOGY IS NOT UNDERSTOOD. ONE STUDY FOUND THAT ELECTRODE IMPLANTATION INDUCED OFF FOG IN SOME PATIENTS. IN CONTRAST, WE REPORT A UNIQUE CASE OF STN ELECTRODE IMPLANTATION ACUTELY INDUCING ON FOG. REPORTED EVENT: A (B)(6) MALE EXPERIENCED NEW ONSET OF ON-PHASE FREEZING OF GAIT (ON FOG) IMMEDIATELY AFTER BILATERAL SUBTHALAMIC NUCLEUS (STN) ELECTRODE IMPLANTATION. THE ON FOG WAS UNRELATED TO STIMULATION AND WAS NOT DUE TO CHANGES IN THE PATIENT¿S PREOPERATIVE ANTI-PARKINSONIAN MEDICATION. AFTER ELECTRODE IMPLANTATION, THE PATIENT SHOWED FOG DURING INITIATION, WALKING ON A STRAIGHTAWAY, OR TURNS. THE ELECTRODES WERE NOTED TO BE ANATOMICALLY WELL POSITIONED AND THERE WAS NO EVIDENCE OF HEMORRHAGE OR OTHER SIGNIFICANT FINDINGS. THE BILATERAL DEEP BRAIN STIMULATION MARKEDLY IMPROVED ALL OTHER FEATURES OF PARKINSONISM. ON FOG WAS UNRESPONSIVE TO TRIALS OF HIGH DOSES OF L-DOPA, RASAGILINE, METHYLPHENIDATE, OR DONEPEZIL. ON FOG WAS PRESENT FOR OVER A YEAR AFTER IMPLANT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE NO OBSERVED DEVICE MALFUNCTIONS AND THE PATIENT DID NOT RECOVER. IT WAS NOTED THAT THE DEVICE WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344151 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7428

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Other| R