BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 3969871 · Received July 31, 2014

    Report

    Report Number
    3007566237-2014-02131
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 19, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    CALIXTO, L., QUINTANEIRO, C., SEABRA, H., GOMES, A., REGALDO, A. M., ARAGAO, I. ET AL. CARDIAC ARREST DUE TO WITHDRAWAL BACLOFEN SYNDROME: A CLINICAL CASE REPORT. RESUSCITATION. 2013. 84 (S92) SUMMARY/REPORTED EVENT: CASE NUMBER PHHY2014PT090146, IS AN INITIAL LITERATURE REPORT RECEIVED ON 19 JUL 2014. AUTHORS DISCUSSED ABOUT CARDIAC ARREST DUE TO WITHDRAWAL BACLOFEN SYNDROME: A CLINICAL CASE REPORT. THIS REPORT REFERS TO A 41 YEAR-OLD PATIENT RECEIVED INTRATHECAL BACLOFEN (MANUFACTURER UNKNOWN) FOR REFRACTORY SPASTICITY AT AN UNSPECIFIED DOSE AND FREQUENCY. THE PATIENT HAD POST TRAUMATIC SPASTIC QUADRIPARESIS AFTER CERVICAL TRAUMA. IN LESS THAN 24 HOURS AFTER PUMP SUBSTITUTION, PATIENT HAD HYPERTHERMIA, SEIZURE, COGNITIVE DEPRESSION, ACUTE HYPOXEMIC RESPIRATORY FAILURE AND CARDIOVASCULAR INSTABILITY LEADING TO MECHANICAL VENTILATION AND VASOPRESSOR SUPPORT AND HOSPITALIZED. IN HOSPITAL, INITIAL INVESTIGATION SHOWED LEUCOCYTOSIS, ELEVATED CREATINE REACTIVE PROTEIN (CRP) AND A LUNG CONDENSATION IN COMPUTERIZED TOMOGRAM (CT) SCAN AND TRANSFERRED TO OUR INTENSIVE CARE UNIT (ICU) DEPARTMENT WITH DIAGNOSIS OF COMMUNITY-ACQUIRED PNEUMONIA LEADING TO SEPTIC SHOCK AND MULTISYSTEM ORGAN FAILURE ON ADMISSION: HEMODYNAMIC INSTABILITY DESPITE FLUIDOTHERAPY, INCREASING NORADRENALINE, HYPERLACTATEMIA, EKG ABNORMALITIES, ELEVATED CARDIAC ENZYMES, RHABDOMYOLYSIS AND ACUTE RENAL FAILURE WITH METABOLIC ACIDOSIS. EVOLUTION TO CARDIAC ARREST IN NON-SHOCKABLE RHYTHM (PULSELESS ELECTRICAL ACTIVITY) - 4 MIN RESUSCITATION AND 1MG OF ADRENALINE WITH RETURN OF SPONTANEOUS CIRCULATION. IN SUSPICION OF ITB DELIVERY DISRUPTION, SURGICAL EXPLORATION OF THE CATHETER SYSTEM WAS MADE, A LEAKING TUBULE ATTACHMENT BETWEEN CATHETER AND PUMP WAS FOUND AND ITB INFUSION WAS REINSTITUTED. OVER THE NEXT DAYS SEDATION AND CURARIZATION NEEDS DRAMATICALLY DECREASED, FEVER AND HEMODYNAMIC INSTABILITY RESOLVED. RENAL SUBSTITUTION TECHNIQUE NEEDED FOR 11 DAYS. DIFFICULT WEANING OFF FROM THE VENTILATOR, PROPER CARE ACHIEVED THROUGH TRACHEOSTOMY TUBE. COMPLETE RECOVERY AND DISCHARGED AFTER 56 DAYS. AUTHOR CONCLUDED THAT BACLOFEN WITHDRAWAL SYNDROME IS A RARE BUT POTENTIALLY LIFE-THREATENING COMPLICATION OF ITB THERAPY IF NOT RECOGNIZED AND TREATED EARLY. PRESENTATION MAY BE AS CARDIAC ARREST OR MULTIPLE ORGAN FAILURE MIMICKING SEVERAL SYNDROMES INCLUDING SEPSIS, SO A HIGH LEVEL OF SUSPICION IS NEEDED. EARLY RECOGNITION, REINSTITUTION OF BACLOFEN AND PROPER ICU MANAGEMENT ARE MAINSTAYS TO PREVENT POTENTIALLY FATAL SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448248 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| L| R