BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2231110 · Received August 26, 2011

    Report

    Report Number
    3007566237-2011-06916
    Event Type
    Injury
    Date Received
    August 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    August 5, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S PUMP WAS ELECTIVELY REPLACED 1.5 MONTHS AGO, AND THE POSTOPERATIVE PERIOD WAS INDICATED AS BEING UNEVENTFUL. THE PATIENT WAS NOTED AS BEING A YOUNG (B)(6). ON (B)(6) 2011, THE PATIENT WAS RE-ADMITTED WITH ELEVATED WHITE BLOOD CELLS (WBC) AND PURULENT WOUND DISCHARGE. IT WAS NOTED THAT THERE WAS AN IMMANENT DANGER OF AN INFECTION SPREADING INTO THE INTRATHECAL SPACE (COLLECTION TRACK ALONG THE CATHETER VIA CT SCAN). THE SOURCE OF THE POCKET AND SYSTEMIC INFECTION WERE NOT CLEAR AT THAT TIME. A URINARY TRACT INFECTION WAS SUSPECTED. THE PATIENT'S URINE WAS DESCRIBED AS BEING OVERTLY CLOUDY AND BLOODY. A PUMP AND CATHETER EXPLANT WITH EXTENSIVE WOUND DEBRIDEMENT, "INCLUDING SUPERFICIAL ABDOMINAL MUSCLE LAYER", WAS PERFORMED ON (B)(6) 2011. BLOOD LOSS WAS NOTED AS BEING APPROXIMATELY 250 MLS. THE PATIENT HAD ADEQUATE POST-SURGICAL PAIN CONTROL; HOWEVER THE PATIENT'S PAIN MANAGEMENT WAS "PROBLEMATIC TO DATE". OPIOD TOXICITIES WERE NOTED AS BEING SEVERE. THE PATIENT WAS DEMONSTRATING HIGH OPIOD USE WHICH WAS INDICATED AS POTENTIALLY HAVING COMPLICATED CARE. ORAL METHADONE (50 MG/DAY) WAS ADMINISTERED TO THE PATIENT IN REGARDS TO HIS SPINAL CORD INJURY RELATED PAIN. ON THE PATIENT'S FIRST POSTOPERATIVE DAY (POD), AN EVENING NURSE REPORTED THAT THE PATIENT WAS LESS ALERT. THE PATIENT EXPERIENCED COGNITIVE DYSFUNCTION. DURING THE EARLY POSTOPERATIVE PERIOD THE PATIENT RECEIVED ORAL BACLOFEN: 40 MG ON THE DAY OF SURGERY, 140 MG ON POD 1, AND 50 MG ON THE MORNING OF POD 2. THE FOLLOWING ADDITIONAL MEDICATIONS AND DAYS WERE NOTED: DIAZEPAM, METHADONE, AND SCOPOLAMINE PATCH ON POD 1; AND METHADONE POD 2. ON POD2 THE PATIENT BECAME DIAPHORETIC AND TREMULOUS. THE PATIENT WAS GIVEN BOLUSES OF DILAUDID, AND WAS USING DILAUDID PCA UNTIL BECOMING DIAPHORETIC. THE PATIENT RECEIVED BOLUSES OF LORAZEPAM FOR SEIZURE CONTROL. THE PATIENT WAS TRANSFERRED TO THE ICU. IN THE ICU, THE PATIENT'S MENTAL STATUS HAD DETERIORATED, HOWEVER HE REMAINED RESPONSIVE TO STIMULI. AIRWAY VENTILATION WAS BEING MAINTAINED VIA AN OXYGEN NASAL CANNULA. IT WAS DETERMINED THAT THE CLINICAL PICTURE WAS MOST PROBABLY RELATED TO BACLOFEN WITHDRAWAL. A CATHETER WAS INSERTED AT THE LEFT OF L3; AND THE PATIENT RECEIVED A 50 MCG OF BACLOFEN FOLLOWED BY 20 MCG/H INFUSION. THE PATIENT'S STATUS REMAINED UNCHANGED FOR THE NEXT 12 HOURS. SEDATIVES, ORAL BACLOFEN, AND PATIENT-CONTROLLED ANALGESIA (PCA) WERE STOPPED. ONLY METHADONE WAS CONTINUED. INTRATHECAL INFUSION WAS DECREASED, AND ON POD 3 THE PATIENT WAS MORE ALERT AND ABLE TO STATE HIS NAME. THE PATIENT HOWEVER HAD BECOME MORE RESTLESS AND COMPLAINED OF PAIN. THE PATIENT RECEIVED INTRAVENOUS DILAUDID, AND BACLOFEN INFUSION WAS INCREASED. THE PATIENT'S MENTAL STATUS DECLINED AGAIN. TOWARD THE EVENING OF POD 3, THE LEVEL OF CONSCIOUSNESS IMPROVED. DURING THE PATIENT STAY AT THE ICU, THE PATIENT WAS TREATED WITH "ABX, HYDRATION, ETC." THE PATIENT'S URINE WAS NOTED AS HAVING HAD RETURNED TO NORMAL; AND CK AND WBC HAD NORMALIZED. IT WAS NOTED THAT THE PATIENT'S LAB FINDINGS SHOWED MILD METABOLIC ACIDOSIS, WHITE BLOOD CELL COUNT OF 22000, LACTATE 2.0, CREATININE KINASE (CK) ABOUT 4000, AND CREATININE (CR) OF 1.25. THE PATIENT'S WOUND WAS (B)(6), AND MIXED ORGANISMS IN THE PATIENT'S URINE WAS INDICATED. THE PATIENT'S CEREBROSPINAL FLUID (CSF) WAS STERILE. NEUROMUSCULAR ASSESSMENT REVEALED: "LE MAS (0)", INCREASED TONUS OF UPPER BODY (BUT NOT UPPER EXTREMITY), AND PERIODIC DYSTONIC SHOULDER MOVEMENT. IT WAS NOTED THAT THE INCREASED TONUS AND DYSTONIA WERE NOT NEW, AND DID NOT INCREASE IN COMPARISON OF THE PREOPERATIVE LEVEL. THE PATIENT WAS TRANSFERRED TO THE REGULAR FLOOR ON POD 4. THE PATIENT WAS STILL RECEIVING INTRATHECAL BACLOFEN, AND IT WAS PLANNED TO WEAN THE BACLOFEN BY 10% PER DAY; AND SLOWLY REINSTITUTE ORAL BACLOFEN. THE PATIENT'S INCREASED UPPER BODY TONUS AND LOWER EXTREMITY "MAS" REMAINED THE SAME DURING THIS PERIOD. THE DRUG USED IN THE PUMP AT THE TIME OF THE EVENT WAS BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization