BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6064901 · Received October 28, 2016

    Report

    Report Number
    3007566237-2016-03799
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    August 16, 2015
    Report Date
    December 14, 2016
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM INVOLVED IN THE REPORTED EVENT; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS FILED AS MANUFACTURING REPORT #3007566237-2016-03799. ADDITIONAL REVIEW SHOWED THE CORRECT MANUFACTURING SITE WAS SITE # (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    JOCHIM, A., GEMPT, J., DESCHAUER, M., SCHWARZ, J., KIRSCHKE, J.S., HASLINGER, B. STATUS EPILEPTICUS AFTER SUBTHALAMIC DEEP BRAIN STIMULATION SURGERY IN A PATIENT WITH PARKINSON S DISEASE. WORLD NEUROSURGERY.2016. AUG 24. 1878. SUMMARY: SUBTHALAMIC DEEP BRAIN STIMULATION IS A WELL-ESTABLISHED TREATMENT FOR PATIENTS WITH PARKINSON´S DISEASE WHO SUFFER FROM SEVERE MOTOR FLUCTUATIONS. THE MOST COMMON SURGERY-RELATED COMPLICATIONS ARE TEMPORARY CONFUSION, BLEEDINGS, INFECTIONS AND SEIZURES. SEIZURES HAVE BEEN DESCRIBED TO OCCUR MAINLY AROUND THE TIME OF THE IMPLANTATION OF ELECTRODES AND THE SO FAR BEST ESTABLISHED RISK FACTORS FOR SEIZURES IN ASSOCIATION WITH DEEP BRAIN STIMULATION SURGERY ARE BLEEDINGS. A POSTOPERATIVE STATUS EPILEPTICUS AS COMPLICATION OF DEEP BRAIN STIMULATION SURGERY HAS NEVER BEEN DESCRIBED BEFORE. REPORTED EVENTS: A (B)(6) FEMALE PATIENT WHO RECEIVED SUBTHALAMIC NUCLEUS (STN) DEEP BRAIN STIMULATION (DBS) TO TREAT AKINETIC-RIGID PARKINSON'S DISEASE (PD) WITH NO PERSONAL OR FAMILIAL HISTORY OF EPILEPSY EXPERIENCED SOMNOLENCE FOLLOWED BY STATUS EPILEPTICUS FOLLOWING DEVICE IMPLANT. A BENEFICIAL, CURRENT-DEPENDENT CLINICAL EFFECT ON RIGIDITY AND AKINESIA WAS SEEN ON BOTH SIDES DURING INTRAOPERATIVE STIMULATION, AND OVERALL THEY REPORTED THERE WERE NO INTRAOPERATIVE ADVERSE EVENTS OTHER THAN ANTIHYPERTENSIVE TREATMENT BETWEEN THE END OF MACROSTIMULATION AND THE RESTART OF SEDATION (MEAN ARTERIAL PRESSURE 130 MMHG). ALSO, IN THE MOMENT OF EXTUBATION, A SINGLE 26 DOSE OF 5 MG URAPIDIL I.V. WAS REQUIRED FOR TREATMENT OF A SYSTOLIC BLOOD PRESSURE OF 200 MMHG. ON THE DAY AFTER THE OPERATION, THE PATIENT WAS SOMNOLENT, BUT ABLE TO DRINK AND SPEAK A FEW WORDS. LEVODOPA MONOTHERAPY WAS CONTINUED AND A CRANIAL CT CONFIRMED A CORRECT POSITIONING OF THE DBS LEADS WITHOUT EVIDENT SIGNS OF A BLEEDING AS FAR AS DBS LEAD ARTEFACTS ALLOWED TO DISCRIMINATE. HOWEVER, THE SOMNOLENCE INCREASED AND THE PATIENT EXPERIENCED THREE FOCAL CLONIC SEIZURES OF THE RIGHT HAND IN THE THIRD NIGHT 1 AFTER SURGERY. ANTICONVULSANT THERAPY WITH LEVETIRACETAM (3 G/DAY) WAS STARTED. AN ELECTROENCEPHALOGRAM (EEG) SHOWED A PATTERN WITH GENERALIZED SHARP WAVES OCCURRING NEARLY CONTINUOUSLY WITH A FREQUENCY OF APPROXIMATELY 2 HZ INDICATING STATUS EPILEPTICUS AND DISAPPEARING AFTER INJECTION OF 2 MG LORAZEPAM INTRAVENOUSLY (I.V., FIGURE 2). CLINICALLY, THE PATIENT IMPROVED FOR A SHORT PERIOD, AS SHE SPOKE A FEW WORDS AND APPEARED MORE AWAKE. NEVERTHELESS, SHE BECAME MORE SOMNOLENT AGAIN AND FINALLY COMATOSE DESPITE THE COMBINATION OF LEVETIRACETAM AND VALPROATE (75-110 MG/HOUR) AND REQUIRED PROLONGED INTENSIVE CARE THERAPY COMPRISING ARTIFICIAL VENTILATION AND REPEATED ANESTHESIA USING PROPOFOL OR THIOPENTAL DUE TO AN ONGOING NON-CONVULSIVE STATUS EPILEPTICUS, THAT WAS DOCUMENTED BY REPEATED EEGS SHOWING LEFT-DOMINANT EPILEPTIFORM DISCHARGES. TEMPORARY ADDITIONAL TREATMENT INCLUDED LACOSAMIDE (200 MG/DAY), PHENYTOIN (12-15 MG/HOUR I.V., LATER 450 MG/D PER GAVAGE) AND TOPIRAMATE (100 MG/D PER GAVAGE). INTERRUPTION OF VALPROATE TREATMENT FOR SIX DAYS DUE TO AN INCREASE OF BLOOD AMMONIA (108 UG/DL, REFERENCE RANGE 20-80 UG/DL) AS WELL AS A HIGH DOSE TREATMENT WITH METHYLPREDNISOLONE (1G/DAY OVER FIVE DAYS I.V.) CONSIDERING A POSSIBLE (AUTO)IMMUNOLOGIC PROCESS HAD NO CLINICAL EFFECT. REPEATED MRI (1.5 T, SIEMENS AVANTO) SHOWED SMALL BLEEDINGS IN THE COURSE OF THE LEFT LEAD, MOST PRONOUNCED NEXT TO THE LATERAL VENTRICLE AND AT THE TIP REACHING INTO THE MESENCEPHALON AND A SMALL FRONTOTEMPORAL SUBARACHNOID HEMORRHAGE NEAR THE ENTRY POINT OF THE LEFT LEAD. NO CORTICAL GREY MATTER LESION WAS DETECTED. EXTENSIVE BLOOD LABORATORY ANALYSES INCLUDING CEREBRAL SPINAL FLUID TESTING FOR 14-3- 3- PROTEIN AND NMDA-RECEPTOR ANTIBODIES REVEALED NO EXPLANATORY FINDINGS. EIGHT WEEKS AFTER SURGERY THE PATIENT REGAINED CONSCIOUSNESS, EPILEPTIFORM PATTERNS DECREASED IN THE EEG AND DBS WAS COMMENCED WITH INITIALLY MODERATE EFFECT ON PD SYMPTOMS AND SUBSEQUENT CONTINUOUS IMPROVEMENT. IN THE FOLLOWING MONTHS, SHE HAD MILD, DISTAL PARESES ATTRIBUTED TO CRITICAL ILLNESS NEUROPATHY, BUT COMPARED TO THE PREOPERATIVE STATE LESS DISABLING AKINESIA OR BOTHERING DYSKINESIA. UNFORTUNATELY, COGNITIVE DEFICITS AND APRAXIA PERSISTED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CORRESPONDING AUTHOR INDICATED THAT THE PATIENT FIRST BEGAN EXPERIENCING THE REPORTED EVENT ON (B)(6) 2015, AND ALSO PROVIDED THE DEVICE SERIAL NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714671 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Life Threatening| R