BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEUROSTIMULATOR

    MDR report key: 2513768 · Received April 2, 2012

    Report

    Report Number
    3007566237-2012-00648
    Event Type
    Injury
    Date Received
    April 2, 2012
    Date of Event
    September 15, 2011
    Report Date
    March 23, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. 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. (B)(4). LEAD MODEL 3387 LOT# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK; LEAD MODEL 3387 LOT# UNKNOWN IMPLANTED: UNK EXPLANTED: UNK.

    Description of Event or Problem · 1

    SCHILBACH, L., WEISS, P. H., KUHN, J., TIMMERMANN, L., KLOSTERKOTTER, J., HUFF, W. PHARMACOLOGICAL TREATMENT OF DEEP BRAIN STIMULATION-INDUCED HYPOMANIA LEADS TO CLINICAL REMISSION WHILE PRESERVING MOTOR BENEFITS. NEUROCASE 2012. 18(2): 152-159. DOI: 10.1080/13554794.2011.568502. SUMMARY: DEEP BRAIN STIMULATION (DBS) OF THE SUBTHALAMIC NUCLEUS (STN) IS AN EFFECTIVE TREATMENT FOR PARKINSON'S DISEASE, BUT CAN LEAD TO ADVERSE EFFECTS INCLUDING PSYCHIATRIC DISTURBANCE. LITTLE IS KNOWN ABOUT THE RISK FACTORS AND TREATMENT OPTIONS FOR SUCH EFFECTS. HERE, WE DESCRIBE A PATIENT WHO REPRODUCIBLY DEVELOPED STIMULATION-INDUCED HYPOMANIA WHEN USING VENT RALLY LOCATED ELECTRODES AND RESPONDED WELL TO PHARMACOLOGICAL INTERVENTION WHILE LEAVING THE STIMULATION PARAMETERS UNCHANGED TO PRESERVE MOTOR BENEFITS. IN SPITE OF CLINICAL REMISSION, [15O]-POSITRON-EMISSION-TOMOGRAPHY (PET) DEMONSTRATED ACTIVATION PATTERNS SIMILAR TO THOSE REPORTED DURING MANIA. THIS CASE, THEREFORE, HIGHLIGHTS AN IMPORTANT TREATMENT OPTION OF ADVERSE EFFECTS OF DBS, BUT ALSO POINTS TOWARD THE NEED FOR INVESTIGATIONS OF ITS RISK FACTORS AND THEIR UNDERLYING NEUROBIOLOGICAL MECHANISMS. REPORTED EVENT: THE PATIENT WAS IMPLANTED WITH DEEP BRAIN STIMULATION IN 2007, RESULTING IN AN IMPROVEMENT OF MOTOR IMPAIRMENTS. SEVERAL MONTHS AFTER THE IMPLANTATION, THE PATIENT DEVELOPED A RIGHT-SIDED SUBDURAL HEMATOMA, WHICH REQUIRED SURGICAL INTERVENTION. AFTER THE OPERATION, THE PATIENT MADE A FULL RECOVERY AND LEAD LOCATION WAS CONTROLLED BY MEANS OF NEUROIMAGING. SUBSEQUENTLY, BILATERAL STIMULATION OF STN RESULTED IN SIGNIFICANT IMPROVEMENT OF MOTOR IMPAIRMENT COMPARABLE TO THE BENEFIT OBSERVED PRIOR TO THE SUBDURAL HEMATOMA. OVER THE NEXT TWO YEARS, HOWEVER, THE DBS HAD TO BE ADJUSTED TO RELY MORE ON THE VENTRAL CONTACTS DUE TO THE PROGRESSIVE DEVELOPMENT OF SIGNIFICANT MOTOR IMPAIRMENT. SWITCHING TO THESE CONTACTS, HOWEVER, ALSO LEAD TO THE DEVELOPMENT OF TWO HYPOMANIC EPISODES THAT REQUIRED HOSPITALIZATION. DURING EACH EPISODE, VOLTAGE APPLIED TO THE VENTRAL CONTACTS WAS REDUCED TO LIMIT THE HYPOMANIC SYNDROME, BUT EVENTUALLY STN-DBS HAD TO BE RE-SET TO THE DORSAL CONTACTS, LEADING TO A SIGNIFICANT WORSENING OF MOTOR SYMPTOMS. DUE TO THE MOTOR IMPAIRMENT APPARENT UPON ADMISSION AND IN AGREEMENT WITH THE PATIENT, STN-DBS WAS AGAIN SWITCHED TO THE "VENTRAL" STIMULATION AS THIS CONFIGURATION HAD BEEN MOST SUCCESSFUL IN TREATING MOTOR SYMPTOMS AND IN SPITE OF THE FACT THAT THIS STIMULATION SETTING HAD PREVIOUSLY LED TO STIMULATION-INDUCED HYPOMANIA. WITHIN MINUTES, A SIGNIFICANT IMPROVEMENT OF MOTOR FUNCTIONS AND CHANGE IN MENTAL STATUS COULD BE OBSERVED. THE PATIENT WAS ABLE TO WALK WITH THE HELP OF A CANE, BEGAN TO SPEAK MORE QUICKLY AND APPEARED MORE ANIMATED AND EXPRESSIVE IN MIMIC AND GESTURE. HE ALSO DESCRIBED A SENSE OF INVIGORATION AND IMPROVEMENT IN MOOD. WITHIN DAYS THE CHANGES IN COGNITION AND BEHAVIOR BECAME MORE PRONOUNCED, FINALLY RESULTING IN A HYPOMANIC SYNDROME (AS MEASURED BY THE YOUNG MANIA RATING SCALE). IN ORDER TO PRESERVE THE MOTOR BENEFITS THE STIMULATION PARAMETERS WERE LEFT UNCHANGED THIS TIME AND THE PATIENT UNDERWENT PHARMACOLOGICAL TREATMENT. THE DOSAGE OF VALPROATE AND CLOZAPINE WERE INCREASED WHILE LEAVING THE ANTI-PARKINSONIAN MEDICATION UNCHANGED. THIS ADJUSTMENT RESULTED IN REMISSION OF THE HYPOMANIC SYNDROME WITHIN THE NEXT WEEK WHILE PRESERVING MOST OF THE MOTOR BENEFITS. IN SPITE OF THE CLINICAL REMISSION, PSYCHOPATHOLOGICAL DIFFERENCES IN THE PATIENT CONTINUED TO BE OBSERVABLE DEPENDING UPON THE STIMULATION SITE: THIS WAS ASSESSED EIGHT WEEKS LATER AND REPRODUCIBLY DEMONSTRATED "DORSAL" STIMULATION TO RESULT IN A DECREASE OF PSYCHOMOTOR FUNCTION AND LOWERING OF HIS MOOD, WHILE SWITCHING BACK TO "VENTRAL" STIMULATION WOULD INCREASE HIS RATE OF SPEECH AND HIS SUBJECTIVE SENSE OF WELL-BEING IMMEDIATELY. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: THE PATIENT W AS IMPLANTED WITH BILATERAL QUADRIPOLAR ELECTRODES (LEAD MODEL 3387 LOT# UNKNOWN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R