BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3854054 · Received June 6, 2014

    Report

    Report Number
    3007566237-2014-01555
    Event Type
    Injury
    Date Received
    June 6, 2014
    Report Date
    May 13, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT ADDITIONAL INFORMATION REGARDING THE REPORTED EVENT. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    PAULS, K. A., HAMMESFAHR, S., MORO, E., MOORE, P., BINDER, E., EL MAJDOUB, F., FINK, G., VOLKER, S., KRAUSS, J., MAAROUF, M., TIMMERMANN, L. DEEP BRAIN STIMULATION IN THE VENTROLATERAL THALAMUS/SUBTHALAMIC AREA IN DYSTONIA WITH HEAD TREMOR. MOVEMENT DISORDERS: OFFICIAL JOURNAL OF THE MOVEMENT DISORDER SOCIETY. 2014; VOL. 00 (00). DOI: 10.1002/MDS.25884. SUMMARY: PALLIDAL DEEP BRAIN STIMULATION (GPI-DBS) EFFECTIVELY AMELIORATES IDIOPATHIC DYSTONIA, ALTHOUGH APPROXIMATELY 15% OF PATIENTS RESPOND INSUFFICIENTLY. ALTHOUGH VARIOUS THALAMIC AND SUBTHALAMIC TARGETS HAVE BEEN SUGGESTED FOR DYSTONIC TREMOR, NO SYSTEMATIC STUDIES HAVE BEEN PUBLISHED ON THALAMIC DBS IN DYSTONIC TREMOR. WE ASSESSED THE EFFECT OF THALAMIC/SUBTHALAMIC AREA DBS (TH-DBS) ON DYSTONIC HEAD TREMOR AND DYSTONIA IN A SINGLE-BLIND DESIGN. DYSTONIC HEAD TREMOR AND DYSTONIA BEFORE AND 3 MONTHS AFTER SURGERY WERE QUANTIFIED VIA BLINDED VIDEO-RATINGS USING THE FAHN-TOLOSA-MARIN-TREMOR-SCALE AND THE BURKE-FAHN-MARSDEN-DYSTONIA-RATING-SCALE IN SEVEN PATIENTS WITH IDIOPATHIC CERVICAL OR SEGMENTAL DYSTONIA, DYSTONIC HEAD TREMOR, AND BILATERAL TH-DBS. PAIN, SIDE EFFECTS, ADVERSE EVENTS, AND STIMULATION PARAMETERS WERE ASSESSED. TH-DBS IMPROVED DYSTONIC TREMOR AND DYSTONIA (P <(><<)> 0.05; 57.1% AND 70.4%, RESPECTIVELY). HEAD TREMOR AMPLITUDE AND PAIN WERE ALSO IMPROVED (P <(><<)> 0.05; 77.5% AND 90.0%, RESPECTIVELY). SIDE EFFECTS INCLUDED DYSARTHRIA, GAIT DISTURBANCE, SLOWNESS OF MOVEMENT, AND WEIGHT GAIN. DYSTONIC HEAD TREMOR AND DYSTONIA CAN BE IMPROVED WITH TH-DBS. REPORTED EVENT: ONE (B)(6) FEMALE PATIENTS EXPERIENCED DEPRESSION WITH SUICIDAL THOUGHTS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: KINETRA MODEL 7428 AND LEAD MODEL 3387 FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330898 KINETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR Life Threatening