BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 2152261 · Received June 23, 2011

    Report

    Report Number
    3007566237-2011-04699
    Event Type
    Malfunction
    Date Received
    June 23, 2011
    Date of Event
    May 12, 2010
    Report Date
    August 9, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    LITERATURE: ASTROM M, TRIPOLITI E, HARIZ MI, ET AL. PT-SPECIFIC MODEL-BASED INVESTIGATION OF SPEECH INTELLIGIBILITY AND MOVEMENT DURING DEEP BRAIN STIMULATION, STEREOTACT FUNCT NEUROSURG. 2010;88(4):224-233. SUMMARY: THIS ARTICLE INVESTIGATED THE ANATOMICAL ASPECTS OF THE ELECTRIC FIELD IN RELATION TO EFFECTS ON SPEECH AND MOVEMENT DURING DEEP BRAIN STIMULATION (DBS) IN THE SUBTHALAMIC NUCLEUS USING THREE DIMENSIONAL PT-SPECIFIC FINITE ELEMENT COMPUTER MODELS OF BILATERAL DBS FOR STIMULATION OF ELECTRIC FIELDS IN 10 PATIENTS. THE MODELS WERE BASED ON POST-OPERATIVE MRI IMAGING. EVENT: THE LEAD IN ONE PT WHO DID NOT SUFFER FROM STIMULATION-INDUCED SPEECH IMPAIRMENTS DURING DBS WAS "PULLED UP" APPROX 2.5MM, ONE WEEK AFTER POSTOPERATIVE MRI IMAGES WERE TAKEN. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. AT THIS TIME NO ADD'L INFO WAS AVAILABLE, ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1