BEUDAMED
    FDA Adverse Event Death Summary report: N

    KINETRA

    MDR report key: 1441741 · Received August 11, 2009

    Report

    Report Number
    2182207-2009-05483
    Event Type
    Death
    Date Received
    August 11, 2009
    Date of Event
    June 20, 2009
    Report Date
    July 17, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SEE SCANNED PAGES.

    Description of Event or Problem · 1

    LITERATURE: PINSKER MO, VOLKMANN J, FALK D, ET AL. DEEP BRAIN STIMULATION OF THE INTERNAL GLOBUS PALLIDUS IN DYSTONIA: TARGET LOCALIZATION UNDER GENERAL ANAESTHESIA. ACTA NEUROCHIR (WIEN); 2009;151(7):751-758. SUMMARY: THIS ARTICLE PRESENTS A SINGLE CENTER EXPERIENCE OF 44 CONSECUTIVE OPERATIONS ON 42 PATIENTS WITH GENERAL, FOCAL OR SEGMENTAL DYSTONIA UNDERGOING DBS IMPLANTATION WITH THE TARGET SITE IN THE GLOBUS PALLIDUS INTERNUS, ALL DONE UNDER GENERAL ANESTHESIA, USING MRI BASED STEREOTACTIC ANATOMICAL TARGETING, INTRA-OPERATIVE MER, AND TEST STIMULATION TO DETERMINE ELECTRICAL THRESHOLDS OF ADVERSE EFFECTS. REPORTABLE EVENT: ONE PATIENT HAD A SYMPTOMATIC INTRACEREBRAL HEMORRHAGE INTO THE RIGHT HEMISPHERE AFTER IMPLANTATION OF THE PERMANENT ELECTRODE, DESPITE INSERTION OF ONLY ONE TEST ELECTRODE BASED ON THE MRI. SHE HAD A GOOD NEUROLOGICAL RECOVERY, BUT SUFFERED A SECOND, FATAL HEMORRHAGE IN THE AFFECTED HEMISPHERE THREE MONTHS AFTER SURGERY. THE PATIENT'S DEATH WAS BELIEVED TO BE RELATED TO THE DBS SURGICAL PROCEDURE. SEE ATTACHED LITERATURE ARTICLE.

    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 Death EXPLANTED:| LEAD: MODEL UNK| LEAD: MODEL LEADMVD| IMPLANTED:| IMPLANTED:| EXPLANTED: