BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 5785241 · Received July 12, 2016

    Report

    Report Number
    3007566237-2016-02591
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    September 14, 2015
    Report Date
    July 12, 2016
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. 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

    LEE, H.M., RUGGOO, V., GRAUDINS, A. INTRATHECAL CLONIDINE PUMP FAILURE CAUSING ACUTE WITHDRAWAL SYNDROME WITH 'STRESS-INDUCED' CARDIOMYOPATHY. JOURNAL OF MEDICAL TOXICOLOGY. 2016;12(1):134-138. DOI 10.1007/S13181-015-0505-9 SUMMARY: WE DESCRIBE A CASE OF CLONIDINE WITHDRAWAL CAUSING LIFE THREATENING HYPERTENSIVE CRISIS AND STRESS-INDUCED CARDIOMYOPATHY. REPORTED EVENTS: A (B)(6) MAN PRESENTED TO THE EMERGENCY DEPARTMENT (ED) AFTER AN EPISODE OF COLLAPSE AT HOME WITH COMPLAINTS OF BACK PAIN, STOMACH CRAMPS, NAUSEA AND VOMITING. HIS ONLY RELEVANT PAST MEDICAL HISTORY INCLUDED BACK PAIN FROM A WORK INJURY 15 YEARS PRIOR. HE HAD UNDERGONE LUMBAR SPINAL SURGERY WITH LIMITED SUCCESS RESULTING IN CHRONIC LOWER BACK PAIN. THIS WAS MANAGED BY A REHABILITATION AND PAIN SPECIALIST WITH A CONTINUOUS INTRATHECAL INFUSION OF CLONIDINE AT 550 MCG/24 H VIA AN IMPLANTED INFUSION PUMP IN HIS SUBCUTANEOUS ANTERIOR ABDOMINAL WALL (MEDTRONIC IMPLANTABLE PROGRAMMABLE (B)(4) PUMP). THE PUMP HAD A BATTERY LIFE OF 3¿7 YEARS. THE PATIENT REVEALED THAT DURING THE DAY, THE PUMP HAD EMITTED A WARNING BEEP TO INDICATE MALFUNCTION BUT AS HE HAD A PLANNED REVIEW WITH HIS PAIN SPECIALIST THE FOLLOWING MORNING, HE DECIDED TO WAIT UNTIL THEN TO MENTION THE ALARM. HOWEVER, DURING THE EVENING, HE DEVELOPED WORSENING SYMPTOMS OF SEVERE BACK PAIN, HEADACHE, NAUSEA, VOMITING AND GENERAL MALAISE. WHILST COLLECTING MAIL IN HIS FRONT YARD, HE FELT UNWELL AND COLLAPSED. HE WAS FOUND A FEW MINUTES LATER AND AN AMBULANCE WAS CALLED. ON ARRIVAL AT THE SCENE, THE PARAMED IC FOUND HIM TO BE HYPERTENSIVE AND DIAPHORETIC. HE WAS TREATED WITH SUBLINGUAL GLYCERYL TRINITRATE (GTN). ON ARRIVAL TO THE ED, HE WAS ALERT AND ORIENTED BUT COMPLAINING OF SEVERE GENERALIZED PAIN. HIS VITAL SIGNS WERE: TEMPERATURE 37.8 °C, PULSE 90 BPM, BP 176/103 MMHG, OXYGEN SATURATION 100 % ON ROOM AIR. HIS BLOOD SUGAR LEVEL WAS 11.8 MMOL/L(3.0¿7.7). A 12-LEAD ECG SHOWED A SINUS RHYTHM WITH NORMAL QRS AND QT. FROM THE HISTORY OF POTENTIAL PUMP FAILURE, IT WAS RECOGNIZED THAT THE PATIENT MIGHT BE SUFFERING FROM ACUTE CLONIDINE WITHDRAWAL. HE WAS PROMPTLY GIVEN AN INTRAVENOUS BOLUS OF 150 MCG OF CLONIDINE AND STARTED ON AN INFUSION AT 50 MCG/H. LABORATORY EXAMINATION REVEALED HAEMOGLOBIN 166 G/L (130¿180 G/L), WHITE BLOOD CELL COUNT 18.9×109/L (4.0¿11.0), PLATELETS 222×109/L (150¿450), WITH NORMAL UREA, ELECTROLYTES, CREATININE AND LIVER FUNCTION TESTS. THE PATIENT WAS ADMITTED TO THE ED SHORT STAY UNIT (SSU) ON AN INTRAVENOUS CLONIDINE INFUSION WITH A PLAN FOR HIM TO BE REVIEWED BY HIS PAIN SPECIALIST IN THE MORNING. FIVE HOURS POST-PRESENTATION, HE BECAME ACUTELY UNWELL, REPORTING SEVERE CRUSHING RETROSTERNAL CHEST PAIN AND SEVERE DYSPNOEA. HIS PULSE WAS 150 BPM, BP 180/120 MMHG AND OXYGEN SATURATION 82 % ON ROOM AIR. EXAMINATION OF HIS CHEST REVEALED WIDESPREAD INSPIRATORY CRACKLES. AN ECG DONE AT THIS TIME SHOWED A SINUS TACHYCARDIA WITH NON-SPECIFIC ECG CHANGES (FIG. 1). CHEST X-RAY SHOWED A NORMAL HEART SIZE WITH ACUTE PULMONARY OEDEMA. HE WAS COMMENCED ON NON-INVASIVE BILEVEL VENTILATION. AT THIS STAGE, THE ON-CALL CLINICAL TOXICOLOGIST WAS CONSULTED WHO ADVISED ADMINISTRATION OF TITRATED DOSES OF INTRAVENOUS CLONIDINE (25 MCG) FOR BLOOD PRESSURE AND SYMPTOM CONTROL AND AN INCREASE IN THE CLONIDINE INFUSION RATE. INTRAVENOUS GTN WAS ALSO COMMENCED ALONG WITH INTRAVENOUS DIAZEPAM FOR ASSOCIATED ANXIETY. THE PATIENT WAS TRANSFERRED TO ICU FOR ONGOING MANAGEMENT AND CARDIAC AND INVASIVE BLOOD PRESSURE MONITORING. AS THERE WAS NO DOCUMENTED DOSE EQUIVALENCE BETWEEN INTRATHECAL AND INTRAVENOUS CLONIDINE, HIS IV DOSES WERE TITRATED TO BLOOD PRESSURE AND SYMPTOMS. INTERMITTENT INTRAVENOUS DOSES OF CLONIDINE TOTALED 575 MCG IN THE FIRST 24 H POST-PRESENTATION WITH THE ASSOCIATED ONGOING INFUSION TITRATED FROM 0.5 TO A MAXIMUM OF 4 MCG/KG/H. A SUMMARY OF HAEMODYNAMICS AND CLONIDINE DOSING IS SHOWN IN FIG. 2. HIS ECG SHOWED DYNAMIC ISCHAEMIC CHANGES AND WITH A TROPONIN-I OF 8.44 MCG/L (0¿0.08) WHICH PEAKED AT 14.34. A BEDSIDE TRANSTHORACIC ECHOCARDIOGRAM PERFORMED THE FOLLOWING MORNING SHOWED REDUCED OVERALL SYSTOLIC FUNCTION WITH SEVERE HYPOKINESIS OF ALL SEGMENTS EXCEPT FOR VIGOROUS CONTRACTIONS OF THE APEX AND MID TO APICAL SEPTUM, CONSISTENT WITH A REVERSE-TAKOTSUBO CARDIOMYOPATHY. A SUBSEQUENT ANGIOGRAM 10 DAYS POST-PRESENTATION SHOWED ONLY MINOR NONCRITICAL CORONARY STENOSIS, AGAIN CONFIRMING THE LIKELY DIAGNOSIS OF A STRESS-INDUCED CARDIOMYOPATHY. CATECHOLAMINE CONCENTRATIONS AND MYOCARDIAL BIOPSY WERE NOT PERFORMED AS THERE WAS AN OBVIOUS PRECIPITANT FOR HIS CARDIOMYOPATHY. THE PATIENT WAS TREATED WITH NON-INVASIVE VENTILATION FOR A TOTAL OF 14 H. WHILST IN ICU, THE GTN INFUSION WAS WEANED IN THE FIRST 24 H AND THE INTRAVENOUS CLONIDINE INFUSION WAS SWITCHED TO ORAL CLONIDINE AFTER 2 DAYS. HE WAS ALSO TREATED WITH ORAL METOPROLOL, CLOPIDOGREL, RAMIPRIL AND ASPIRIN. HIS CLINICAL STATE STABILIZED ON ORAL CLONIDINE REPLACEMENT (150 MCG FIVE TIMES A DAY) AND AFTER 4 DAYS IN ICU, HE WAS TRANSFERRED TO A GENERAL MEDICAL WARD FOR ONGOING CARE. HE WAS DISCHARGED HOME 12 DAYS AFTER PRESENTATION ON ORAL CLONIDINE 150 MCG ORALLY FIVE TIMES A DAY AND ORAL OPIATES FOR BACK PAIN. AN OUTPATIENT TRANSTHORACIC ECHO PERFORMED SIX WEEKS POST-DISCHARGE SHOWED NORMAL LEFT VENTRICULAR SYSTOLIC FUNCTION WITH COMPLETE RESOLUTION OF THE CARDIOMYOPATHY. THE PATIENT WAS MAINTAINED ON ORAL CLONIDINE AND OPIATES FOR HIS BACK PAIN. THE INTRATHECAL PUMP WAS EVENTUALLY SURGICALLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442243 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8626 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Life Threatening| R