BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 1053063 · Received May 23, 2008

    Report

    Report Number
    2182207-2008-02789
    Event Type
    Death
    Date Received
    May 23, 2008
    Report Date
    April 23, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    JOURNAL REFERENCE: WIDER C, POLLO C, BLOCH J, BURKHARD PR, VINGERHOETS FJG. LONG-TERM OUTCOME OF 50 CONSECUTIVE PARKINSON'S DISEASE PATIENTS TREATED WITH SUBTHALAMIC DEEP BRAIN STIMULATION. PARKINSONSIM RELAT DISORD 2008;14 (2):114-119. THE AUTHORS DESCRIBE THE LONG-TERM OUTCOME IN 50 CONSECUTIVE ADVANCED PARKINSON'S DISEASE (PD) PATIENTS TREATED WITH SUBTHALAMIC NUCLEUS DEEP BRAIN STIMULATION (STN-DBS). ASSESSMENTS WERE CARRIED OUT AT BASELINE, 6 MONTHS, 2 YEARS, AND 5 YEARS POSTOPERATIVELY. STN-DBS IS AN EFFECTIVE TREATMENT FOR ADVANCED PD PATIENTS, AND THE BENEFICIAL EFFECT IS MAINTAINED AT 5 YEARS. HOWEVER, WORSENING OCCURS OVER TIME DUE TO DISEASE PROGRESSION. THIRTY SEVEN PATIENTS WERE AVAILABLE FOR CLINICAL EVALUATION AT 5 YEARS. REPORTABLE EVENT: AT 4 YEARS POSTOPERATIVELY, THE PATIENT, WHO PREVIOUSLY HAD INFECTION AND REPLACEMENT AT 3 MONTHS, DEVELOPED A TRAUMATIC PURULENT LEFT PARIETAL WOUND, AGAIN S. AUREUS POSITIVE, AND THE ELECTRODE AND CABLE HAD TO BE REMOVED IN THIS SIDE. AFTER A FEW DAYS OF STABLE EVOLUTION UNDER APPROPRIATE ANTIBIOTIC THERAPY, THE PATIENT DIED OF ANAPHYLACTIC SHOCK OF UNIDENTIFIED ORIGIN.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H LEAD MODEL 3389 N=2| EXTENSION MODEL UNK N=2| PROGRAMMER MODEL UNK N=1