BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPANTABLE NEUROSTIMULATOR

    MDR report key: 7558311 · Received May 31, 2018

    Report

    Report Number
    3007566237-2018-01652
    Event Type
    Injury
    Date Received
    May 31, 2018
    Date of Event
    January 1, 2018
    Report Date
    May 31, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: , UDI#:. HSU, CW., LIN, CC., HUANG, TL. A CASE REPORT OF INTRAMUSCULAR LORAZEPAM IN CATATONIA OF A PARKINSON'S DISEASE PATIENT AFTER DEEP BRAIN STIMULATION. PSYCHIATER DANUB. 2018;30(1):104-106. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    SUMMARY: IN DIAGNOSTIC AND STATISTICAL MANUAL (DSM)-5, CATATONIA IS DEFINED BY THE PRESENCE OF THREE OR MORE OF 12 PSYCHOMOTOR DISTURBANCES, WHICH MAY BE ASSOCIATED WITH MENTAL DISORDER OR MEDICAL CONDITION (TANDON ET AL. 2013). CATATONIA COULD BE TREATED WITH BENZODIAZEPINE (BZD) OR ELECTROCONVULSIVE THERAPY (ECT) (LIN & HUANG 2013, HUANG ET AL. 2013, RAVEENDRANATHAN ET AL. 2012). PARKINSON'S DISEASE (PD) IS CHARACTERIZED BY MOTOR DISTURBANCES THAT MANIFESTS AS TREMOR, RIGIDITY, AND BRADYKINESIA. DEEP BRAIN STIMULATION (DBS) IS A SURGICAL PROCEDURE THAT IMPLANTS AN ELECTRICAL PACEMAKER TO DEEP BRAIN STRUCTURES, SUCH AS SUBTHALAMIC NUCLEUS AND THE GLOBUS PALLIDUS INTERNUS. DBS HAS BEEN FOUND TO BE EFFECTIVE IN MANAGING MOTOR PROBLEM FOR REFRACTORY PD (LUKINS ET AL. 2014). THERE HAD BEEN ONLY FEW REPORTS REGARDING CATATONIA IN PATIENT WITH PD (POYRAZ ET AL. 2016) OR IN PATIENTS TREATED WITH DBS (COFFEY ET AL. 2010, QUINN ET AL. 2014). TREATMENT RESPONSES OF BZD IN THOSE REPORTS WERE INCONSISTENT. HERE, WE PRESENT A FEMALE PATIENT WITH PD TREATED WITH DEEP BRAIN STIMULATION (DBS) FOR 18 MONTHS WHO SUDDENLY DEVELOPED CATATONIA DURING HOSPITALIZATION. LITERATURE REGARDING CATATONIA ASSOCIATED WITH PD AND DBS WAS REVIEWED. REPORTED EVENTS: 1. A (B)(6)-YEAR-OLD FEMALE PATIENT WITH BILATERAL DEEP BRAIN STIMULATION (DBS) FOR PARKINSON'S DISEASE (PD) AND A HISTORY OF MAJOR DEPRESSIVE EPISODES/SUICIDE ATTEMPTS REQUIRING PSYCHIATRIC HOSPITALIZATION AND PHARMACOLOGIC TREATMENT EXPERIENCED ANOTHER MAJOR DEPRESSIVE EPISODE APPROXIMATELY 1-YEAR POST-IMPLANT. THE PATIENT PRESENTED WITH AUDITORY HALLUCINATION AND PERSECUTORY DELUSION. UNDER THE IMPRESSION OF MAJOR DEPRESSIVE DISORDER WITH PSYCHOTIC FEATURE, SHE WAS INITIALLY PRESCRIBED WITH MIRTAZAPINE (60 MG/DAY), WHICH IMPROVED HER DEPRESSIVE SYMPTOMS, BUT HER PSYCHOSIS PERSISTED. OLANZAPINE (10 MG/DAY) WAS ADDED, THEN HER PSYCHOTIC SYMPTOMS IMPROVED GRADUALLY WITHOUT PRESENCE OF EXTRAPYRAMIDAL SYNDROME (EPS). AFTERWARD, SHE WAS PRESCRIBED WITH OLANZAPINE (5 MG/DAY) AS MAINTENANCE TREATMENT. AT AGE OF (B)(6), SHE WAS ADMITTED FOR FLUCTUATING CONSCIOUSNESS, DISORIENTATION, POOR ORAL INTAKE, AUDITORY HALLUCINATION AND PERSECUTORY DELUSION, AND AGITATION FOR 5 DAYS. HER FAMILY DENIED RECENT HISTORY OF ILLICIT DRUG USE OR HEAD INJURY. LABORATORYDATA SHOWED HYPOKALEMIA (K: 2.7 MEQ/L). WITHOUT OTHER ELECTROLYTE IMBALANCE, INFECTION, ANEMIA, ABNORMAL RENAL FUNCTION, ELEVATION LIVER ENZYME, OR METABOLIC ABNORMALITIES. UNDER THE IMPRESSION OF HYPOKALEMIA DUE TO POOR ORAL INTAKE FOR 5 DAYS AND THEN DELIRIUM DUE TO HYPOKALEMIA, INTRAVENOUS AND ORAL SUPPLEMENT OF POTASSIUM WERE PRESCRIBED, AND OLANZAPINE (5 MG/DAY) WAS DISCONTINUED. BLOOD POTASSIUM WAS CORRECTED TO 3.4 MEQ/L ON DAY 4. SHE BECAME MORE ORIENTATED BUT REMAINED DROWSY, AND CONTINUED TO HAVE AUDITORY HALLUCINATION, PERSECUTORY DELUSION, DECREASED ACTIVITIES WITH INTERMITTENT AGITATION AND RIGIDITY. ANTICHOLINERGIC DRUG (TRIHEXYPHENIDYL 6 MG/DAY) WAS ADDED FOR RIGIDITY, SUSPECTED TO BE EPS, BUT NO IMPROVEMENT WAS NOTED FROM DAY 4 TO 6. WE THEN SUSPECTED HER RIGIDITY WAS RELATED TO DBS, SO THE NEUROLOGIST WAS CONSULTED ON DAY 6. UPON RE-CALIBRATION OF DBS, HER RIGIDITY IMPROVED ONLY SLIGHTLY. OLANZAPINE (5 MG/DAY) WAS ADDED BACK ON DAY 6 AS WELL, IN ORDER TO TREAT HER PERSISTENT PSYCHOTIC SYMPTOMS. FROM DAY 6 TO 10, SHE REMAINED MOSTLY DROWSY, SILENT, HYPOACTIVE, AND RIGID. HOWEVER, SHE COULD RESPOND TO AND INTERACT WITH THE STAFF DURING THE PERIOD. ON DAY 11, SHE WAS NOTED TO HAVE NO RESPONSE TO EXTERNAL STIMULI, NO VERBAL OUTPUT, FIXED GAZE, AND KEPT SITTING ON A CHAIR WITH THE SAME, UNCOMFORTABLE POSTURE. SHE COULD NOT FOLLOW ORDER AND REFUSED ORAL INTAKE. ACCORDING TO BUSH-FRANCIS CATATONIA RATING SCALE (BFCRS), SHE PRESENTED WITH STUPOR, MUTISM, STARING, POSTURING, RIGIDITY, NEGATIVISM, AND WITHDRAWAL, SCORING 16 POINTS. INTRAMUSCULAR (IM) LORAZEPAM (2 MG) CHALLENGE IMPROVED ALL CATATONIC SYMPTOMS EXCEPT RESIDUAL RIGIDITY AFTER 60 MINUTES, WHEN HER BFCRS SCORE WAS ONLY ONE. THE PATIENT BEGAN TO COMMUNICATE WITH HER CAREGIVERS, AND STARTED EATING. ORAL LORAZEPAM (1 MG THREE TIMES PER DAY) WAS PRESCRIBED. NEUROLOGIST WAS CONSULTED AGAIN FOR RESIDUAL RIGIDITY BUT NO IMPROVEMENT WAS FOUND. ANOTHER SIMILAR EPISODE OF CATATONIA WAS OBSERVED IN THE WEE HOURS BY THE DOCTOR ON CALL, AND ANOTHER INJECTION OF 2 MG OF LORAZEPAM QUICKLY RELIEVED HER CATATONIA. SHE WAS DISCHARGED SMOOTHLY ON DAY 13 WITH MAINTENANCE OLANZAPINE (5 MG/DAY) AND LORAZEPAM (3 MG/DAY). AS OF 8-MONTHS LATER NO RECURRENCE OF CATATONIA HAD OCCURRED. 2. THE 59/60-YEAR-OLD PATIENT WITH DBS FOR PD UNDERWENT A SURGERY FOR DBS ADJUSTMENT APPROXIMATELY 2-3 YEARS AFTER IMPLANT. THE SPECIFIC CAUSE OR NATURE OF THIS ADJUSTMENT WAS NOT REPORTED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401103 UNKNOWN IMPANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other| R