BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR FOR DBS

    MDR report key: 5795213 · Received July 14, 2016

    Report

    Report Number
    3007566237-2016-02637
    Event Type
    Injury
    Date Received
    July 14, 2016
    Date of Event
    April 7, 2016
    Report Date
    July 14, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    NGUYEN, H. S., WOEHLCK, H., PAHAPILL, P. AN UNUSUAL CASE OF ASYSTOLE OCCURRING DURING DEEP BRAIN STIMULATION SURGERY. CASE REPORTS IN NEUROLOGICAL MEDICINE. 2016; 2016:8930296. DOI: 10.1155/2016/8930296 SUMMARY: SYMPTOMATIC BRADYCARDIA AND HYPOTENSION IN NEUROSURGERY CAN PRODUCE SEVERE CONSEQUENCES IF NOT MANAGED APPROPRIATELY. THE LITERATURE IS SCARCE REGARDING ITS OCCURRENCE DURING DEEP BRAIN STIMULATION (DBS) SURGERY. CASE PRESENTATION. A (B)(6) FEMALE PRESENTED FOR LEFT DBS LEAD PLACEMENT FOR ESSENTIAL TREMORS. DURING LEAD IMPLANTATION, HEART RATE AND BLOOD PRESSURE DROPPED RAPIDLY; THE PATIENT BECAME UNRESPONSIVE AND ASYSTOLIC. CHEST COMPRESSIONS WERE INITIATED AND EPINEPHRINE WAS GIVEN. WITHIN 30 SECONDS, THE PATIENT BECAME HEMODYNAMICALLY STABLE AND CONSCIOUS. A HEAD CT DEMONSTRATED NO ACUTE FINDINGS. AFTER DELIBERATION, A DECISION WAS MADE TO COMPLETE THE PROCEDURE. ASSUMING THE ETIOLOGY OF THE EPISODE WAS THE BEZOLD-JARISCH REFLEX (BJR), APPROPRIATE ACCOMMODATIONS WERE MADE. THE PROCEDURE WAS COMPLETED UNEVENTFULLY. THE EPISODE WAS CONSISTENT WITH A MANIFESTATION OF THE BJR. THE PATIENT HAD A HISTORY OF NEUROCARDIOGENIC SYNCOPE AND A RELATIVELY LOW-VOLUME STATE, FACTORS PRONE TO THE BJR. OVERALL, LEAD IMPLANTATION CAN STILL OCCUR SAFELY IF PREVENTIVE MEASURES ARE EMPLOYED. REPORTED EVENT: IT WAS REPORTED A (B)(6) FEMALE PATIENT PRESENTED FOR LEFT DEEP BRAIN STIMULATION (DBS) LEAD PLACEMENT IN THE VENTRAL INTERMEDIATE (VIM) NUCLEUS FOR THE TREATMENT OF ESSENTIAL TREMORS. THE RIGHT-HANDED PATIENT HAD A HISTORY OF VASOVAGAL/NEUROCARDIOGENIC SYNCOPE, IRRITABLE BOWEL SYNDROME, AND HYPOTHYROIDISM AND HAD BEEN SUFFERING FROM ESSENTIAL TREMORS FOR 25 YEARS. NOTABLY, SHE ALSO HAD AN EXTENSIVE FAMILY HISTORY OF NEUROCARDIOGENIC SYNCOPE. EXAM REVEALED BILATERAL UPPER EXTREMITY GRADE 2/4 INTENTION TREMORS. BASELINE VITAL SIGNS INCLUDED (B)(6), BLOOD PRESSURE (BP) 90-100S/50-60S, AND HEART RATE (HR) 60-90S. IT WAS NOTED THE PATIENT POSSESSED A THIN BODY FRAME, WHICH LIKELY PUT HER IN A SENSITIVE, LOW-VOLUME STATE. DURING THE INITIAL LEAD IMPLANT PROCEDURE, THE PATIENT UNDERWENT FRAME-BASED PLACEMENT OF A LEFT VIM DBS LEAD WITH MICRO-RECORDING, WHICH RESULTED IN A SIGNIFICANT LESION EFFECT AND INTRAOPERATIVE TREMOR ARREST WITH MACRO-STIMULATION. IMMEDIATELY POSTOPERATIVELY, THE PATIENT DEMONSTRATED MILD DIFFICULTY WITH COORDINATION AND SPEECH PRODUCTION, AS WELL AS AN ODD SENSATION IN THE RIGHT HAND. A CT SCAN OF THE PATIENT'S HEAD DEMONSTRATED A SMALL HEMORRHAGE AT THE TIP OF THE LEAD. AT THE FIRST PROGRAMMING SESSION, HER INITIAL POSTOPERATIVE SYMPTOMS, INCLUDING HER LESION EFFECT, HAD RESOLVED AND SHE DEMONSTRATED NO BENEFITS FROM STIMULATION. AN MRI OF THE PATIENT'S BRAIN CONFIRMED A SMALL RESOLVING HEMATOMA AT THE TIP OF THE LEAD; CONSEQUENTLY, FURTHER PROGRAMMING WAS HELD OFF UNTIL THE HEMATOMA RESOLVED. A MONTH LATER, DBS PROGRAMMING AGAIN DEMONSTRATED NO BENEFITS; A REVISION SURGERY WAS RECOMMENDED AT THAT TIME. DURING AN INITIAL REVISION ATTEMPT, THE PATIENT FELT NAUSEATED AND PROMPTLY BECAME UNRESPONSIVE DURING THE APPLICATION OF THE STEREOTACTIC FRAME. SINCE THE PATIENT'S VITAL SIGNS WERE STABLE, THE FRAME WAS REMOVED AND THE PATIENT WAS PLACED SUPINELY. WITHIN MINUTES, SHE WAS BACK TO NEUROLOGIC BASELINE. A CT SCAN OF THE PATIENT'S HEAD DEMONSTRATED NO ACUTE FINDINGS. THE REVISION PROCEDURE WAS CANCELLED AT THAT TIME AND THE PATIENT WAS ADMITTED FOR FURTHER EVALUATION. WORKUP INCLUDED MEDICINE, NEUROLOGY, PSYCHIATRY, AND CARDIOLOGY CONSULTATIONS. NO STRUCTURAL HEART DISEASE OR MALIGNANT ARRHYTHMIAS WERE IDENTIFIED. FURTHER HISTORY REVEALED SEVERAL RECENT FAINTING EPISODES. THE EPISODE DURING THE INITIAL REVISION PROCEDURE WAS ATTRIBUTED TO NEUROCARDIOGENIC SYNCOPE. SHE WAS ALSO EVALUATED FOR A POTENTIAL PSYCHIATRIC COMPONENT GIVEN THE FACT THAT THIS OCCURRED A FEW DAYS AWAY FROM WHAT WOULD HAVE BEEN HER LATE HUSBAND'S BIRTHDAY AND A FEW WEEKS FROM THE ONE-YEAR ANNIVERSARY OF HIS DEATH. A DIAGNOSIS OF MAJOR DEPRESSIVE DISORDER RELATED TO GRIEF WAS MADE AND A TRIAL OF MIRTAZAPINE WAS STARTED. SHE REPORTED IMPROVEMENT IN MOOD, APPETITE, AND SLEEP. THREE MONTHS LATER A SECOND REVISION ATTEMPT WAS INITIATED, WHERE FRAME PLACEMENT ENSUED WITHOUT ISSUES. IT WAS NOTED THE PATIENT RECEIVED LIMITED INTRAVENOUS FLUIDS PERIOPERATIVELY TO AVOID HYPERTENSION AND THAT SHE WAS IN A BEACH CHAIR POSITION FOR THE SURGERY, WHICH POTENTIALLY CAUSED VENOUS POOLING. IT WAS ADDITIONALLY NOTED THAT BOTH SHORT- AND LONG-ACTING LOCAL ANESTHETIC WITH EPINEPHRINE WERE UTILIZED FOR THE PROCEDURE. THE PREVIOUS BURR HOLE WAS EXPOSED. AFTER MICROELECTRODE MAPPING, THE DBS ELECTRODE WAS PLACED. PRIOR TO TEST MACRO-STIMULATION THROUGH THE DBS LEAD, THE PATIENT COMPLAINED OF SEVERE NAUSEA. HR DECREASED QUICKLY FROM 80-90S TO 20-30S AND BLOOD PRESSURE FROM 120S/60S TO 60S/30S. THE PATIENT BECAME UNRESPONSIVE AND ASYSTOLIC; RESPIRATORY RATE REMAINED STABLE AT 10-16. CHEST COMPRESSIONS WERE INITIATED IMMEDIATELY BY THE MOVEMENT DISORDER NEUROLOGIST AND ADMINISTRATION OF 0.1 MG EPINEPHRINE OCCURRED INTRAVENOUSLY. SUBSEQUENTLY, WITHIN 30 SECONDS, THE PATIENT DEMONSTRATED A RETURN OF HEMODYNAMIC STABILITY AND BECAME RESPONSIVE, ANSWERING SIMPLE QUESTIONS. THE PATIENT'S HR WAS IN THE 90S TO 100S, AND BP WAS 90S/50S AT THAT TIME. THE REVISION PROCEDURE WAS STOPPED; WHEREBY THE DBS ELECTRODE AND STEREOTACTIC ARC, BUT NOT THE FRAME, WERE REMOVED AND THE INCISION WAS CLOSED. A STAT CT SCAN OF THE PATIENT'S HEAD DID NOT DEMONSTRATE ANY ABNORMALITIES. IT WAS NOTED THE EPISODE HAD OCCURRED 90 MINUTES AFTER HER PREVIOUS BUSS HOLE WAS EXPOSED. THERE WAS NO NEW TREPHINATION, COUGHING EPISODE, OR ELEVATION IN RESPIRATORY RATE TO SUGGEST THAT VENOUS EMBOLISM WAS THE UNDERLYING ETIOLOGY AND FURTHERMORE THE PATIENT'S RAPID CLINICAL COURSE WAS INCONSISTENT WITH VENOUS AIR EMBOLISM. IT WAS FURTHER NOTED THAT WHILE THE PATIENT WAS NOT SEDATED DURING THE DBS IMPLANT PROCEDURE, IRRITATION OF THE DURA WAS LIKELY MINIMAL DURING IMPLANTATION. EXTENSIVE DISCUSSIONS OCCURRED WITH THE PATIENT, THE ANESTHESIA TEAM, THE NEUROLOGY TEAM, AND THE PATIENT'S FAMILY AT THAT TIME. THE DECISION WAS MADE TO BRING HER IMMEDIATELY BACK TO THE OPERATING ROOM AND COMPLETE THE PROCEDURE BY IMPLANTING THE DBS ELECTRODE AS PLANNED. BELIEVING THE ACUTE, DRAMATIC ASYSTOLE EPISODE WAS DUE TO THE BEZOLD-JARISCH REFLEX (BJR), THE PATIENT WAS TREATED WITH GLYCOPYRROLATE AND A 20 ML/KG NORMAL SALINE BOLUS. THERE WAS NO RECURRENCE OF BRADYCARDIA, HYPOTENSION, OR ASYSTOLE; THE PROCEDURE WAS COMPLETED UNEVENTFULLY. TEST STIMULATION THROUGH THE IMPLANTED DBS ELECTRODE REVEALED TREMOR ARREST. THERE WERE NO POSTOPERATIVE CONCERNS AND THE PATIENT WAS DISCHARGED THE FOLLOWING MORNING. THE PATIENT WAS SEEN AT 2 WEEKS' FOLLOW-UP FOR ADJUSTMENT OF HER DBS SETTINGS, WHICH WAS LEFT AT C(+)0(-), 2.2 V, 60US, AND 150HZ WITH TREMOR ARREST AND NO SIDE EFFECTS. AT 14 MONTHS, SHE CONTINUED TO DO WELL AND WAS CONSIDERING PLACEMENT OF A RIGHT DBS ELECTRODE TO CONTROL HER REMAINING LEFT-SIDED TREMORS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449497 IMPLANTABLE NEUROSTIMULATOR FOR DBS STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Life Threatening| R