BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4361888 · Received December 24, 2014

    Report

    Report Number
    3007566237-2014-03777
    Event Type
    Injury
    Date Received
    December 24, 2014
    Date of Event
    November 18, 2014
    Report Date
    December 8, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT DATE REFLECTS THE DATE THAT THE ARTICLE WAS PUBLISHED ONLINE. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. PRODUCT ID: NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    MORR, S., HEARD, C. M., LI, V., REYNOLDS, R. M. DEXMEDETOMIDINE FOR ACUTE BACLOFEN WITHDRAWAL. NEUROCRITICAL CARE. 2014. DOI: 10.100 7/S12028-014-0083-8 SUMMARY/REPORTED EVENT: A (B)(6)-YEAR-OLD MALE BORN AT (B)(6) OF GESTATIONAL AGE WITH A PAPILE GRADE III INTRAVENTRICULAR HEMORRHAGE, PERIVENTRICULAR LEUKOMALACIA, CEREBRAL PALSY, SEVERE DEVELOPMENTAL DELAY, AND SPASTIC QUADRIPARESIS INITIALLY UNDERWENT PLACEMENT OF A SYNCHROMED IIB INTRATHECAL BACLOFEN PUMP 7 YEARS PRIOR TO THE CURRENT PLANNED SURGICAL REVISION. THE PATIENT WAS RECEIVING 220 MICROGRAMS (MCG) OF BACLOFEN DAILY. ONE MONTH PRIOR TO THE PROCEDURE, A ROUND AREA OF SKIN IRRITATION WAS NOTED ON THE LOWER PART OF THE ABDOMEN OVERLYING THE PUMP EDGE. LOCAL WOUND CARE WITH BACITRACIN AND ADDITIONAL PADDING DID NOT IMPROVE THE LESION. PREOPERATIVE PHYSICAL EXAMINATION REVEALED A WELL-NOURISHED, SEVERELY DEVELOPMENTALLY DELAYED, NON-VERBAL MALE WITH SPASTIC QUADRIPARESIS (MODIFIED ASHWORTH SCALE SCORES OF 3 IN THE EXTREMITIES). ABDOMINAL AND LUMBAR INCISIONS WERE WELL HEALED WITHOUT INDURATION OR BREAKDOWN. A 1.0 CM 9 1.0 CM AREA OF ERYTHEMA COULD BE VISUALIZED INFEROMEDIAL TO THE ABDOMINAL INCISION WITH A PALPABLE PUMP EDGE UNDER THE REGION. GIVEN THAT THE PUMP END-OF-LIFE WAS APPROACHING, THE DECISION WAS MADE TO ELECTIVELY RE-IMPLANT A FRESH PUMP WHILE REVISING THE SUBCUTANEOUS POCKET TO ALLEVIATE THE PRESSURE ON THE LOWER ABDOMINAL WALL. THE PATIENT WAS INTUBATED AFTER STANDARD ANESTHETIC INDUCTION. AFTER POSITIONING THE PATIENT IN THE LATERAL DECUBITUS POSITION WITH THE RIGHT SIDE UP, THE LUMBAR AND ABDOMINAL SITES WERE EXPOSED, STERILIZED, AND DRAPED IN THE USUAL FASHION. THE ABDOMINAL INCISION WAS INFILTRATED WITH LIDOCAINE AND OPENED. UPON OPENING THE CAPSULE AROUND THE PUMP, A SLIMY, FIBRINOUS, AND SLIGHTLY PURULENT EXUDATE WAS ENCOUNTERED. THE PUMP WAS EXPLANTED, AND CULTURES WERE OBTAINED FOR MICROBIOLOGIC REVIEW. THE LUMBAR INCISION WAS OPENED, AND THE INTRATHECALLY BOUND CATHETER WAS CLAMPED, AND CUT; 3 ML OF CLOUDY-APPEARING CEREBROSPINAL FLUID WAS COLLECTED FOR MICROBIOLOGICAL ANALYSIS. DUE TO THE SIGNIFICANT CONCERN FOR INFECTION, THE DECISION WAS MADE TO REMOVE THE PUMP SYSTEM. A SUTURE WAS PLACED AT THE FASCIAL EXIT SITE TO PREVENT A CEREBROSPINAL FLUID LEAK. INTRAOPERATIVE FLUOROSCOPY WAS USED TO VERIFY COMPLETE REMOVAL OF THE PUMP-CATHETER SYSTEM. THE WOUNDS WERE CLOSED IN A MULTILAYER FASHION AFTER COPIOUS IRRIGATION. A JACKSON-PRATT DRAIN WAS LEFT WITHIN THE ABDOMINAL POCKET. FOLLOWING REMOVAL OF THE PUMP-CATHETER SYSTEM, THE PATIENT WAS TRANSFERRED WHILE INTUBATED AND RECEIVING PROPOFOL TO THE PEDIATRIC I INTENSIVE CARE UNIT (ICU) FOR CLOSE MONITORING IN LIGHT OF HIS HIGH RISK OF DEVELOPING BACLOFEN WITHDRAWAL. THE MULTIDISCIPLINARY PEDIATRIC SUBSPECIALTY TEAM CARING FOR THE PATIENT INCLUDED CRITICAL CARE MEDICINE, ANESTHESIOLOGY, PHYSIATRY, AND INFECTIOUS DISEASE. THE PATIENT WAS PLACED ON ENTERAL BACLOFEN (30 MG, EVERY 6 H) VIA GASTROSTOMY TUBE AND SCHEDULED INTRAVENOUS LORAZEPAM (0.25 MG, EVERY 6 H) WITH SUPPLEMENTAL LORAZEPAM (0.5 MG DOSES, EVERY 2 H) AS NEEDED. DESPITE THESE MEASURES, THE PATIENT CONTINUED TO HAVE TACHYCARDIA UP TO 140 BEATS PER MINUTES, SYSTOLIC HYPERTENSION UP TO 160 MMHG WITH DIASTOLIC PRESSURES UP TO 90 MMHG, SEVERE REBOUND SPASTICITY WITH ASHWORTH SCALE SCORES OF 4 AND 5, AND FREQUENT INTERMITTENT EPISODES OF SPONTANEOUS CLONUS IN THE LOWER EXTREMITIES. HE WAS SUCCESSFULLY EXTUBATED APPROXIMATELY 36 H POSTOPERATIVELY BUT WAS NOTED TO BE IN SIGNIFICANT DISCOMFORT. FURTHER ESCALATION OF BENZODIAZEPINE USE WAS NOT UTILIZED BECAUSE OF THE REAL DANGER OF RESPIRATORY DEPRESSION. GIVEN THE CONTINUED CONCERN FOR BACLOFEN WITHDRAWAL AS A SOURCE OF THE SYMPTOMATOLOGY AND THE LACK OF IMPROVEMENT WITH STANDARD THERAPIES, INCLUDING UP TO HOURLY ADMINISTRATION OF 0.5¿1 MG OF LORAZEPAM, A DEXMEDETOMIDINE INFUSION WAS COMMENCED ON POSTOPERATIVE DAY 2 AT A RATE OF 6 MCG PER HOUR (0.15 MCG/KG/HR) AND TITRATED FOR CONTROL OF AUTONOMIC INSTABILITY AND TONE TO A PEAK DOSE OF 16 MCG PER HOUR (0.40 MCG/KG/HR). THE PEAK DOSE WAS REACHED OVER APPROXIMATELY 20 H FROM COMMENCEMENT OF INFUSION. THIS DOSE WAS MAINTAINED FOR 3 DAYS, AFTER WHICH THE INFUSION WAS WEANED OVER 36 H. THE PATIENT BECAME NORMOTENSIVE WITHOUT TACHYCARDIA, AND TONE IMPROVED TO ASHWORTH SCORES OF 2 AND 3 WITHIN APPROXIMATELY 6 H OF REACHING THE PEAK DOSE. SIGNS OF PAIN AND AGITATION ALSO IMPROVED. THE DRAIN WAS REMOVED ON POSTOPERATIVE DAY 2. THE CEREBROSPINAL FLUID CULTURES GREW COAGULASE-NEGATIVE STAPHYLOCOCCUS AUREUS FOR WHICH THE PATIENT UNDERWENT A 2-WEEK COURSE OF INTRAVENOUS ANTIBIOTICS WITH CEFTRIAXONE. THE PATIENT WAS TRANSFERRED TO THE FLOOR ON POSTOPERATIVE DAY 12 AND DISCHARGED HOME ON POSTOPERATIVE DAY 14 WITH SCHEDULED ENTERAL BACLOFEN, 25 MG, AND LORAZEPAM, 0.5 MG, EVERY 6 H EACH. THE CLONAZEPAM DOSAGE THAT WAS INITIATED YEARS PREVIOUSLY AS AN ANTIEPILEPTIC AGENT WAS MAINTAINED AT 0.25 MG TWICE DAILY THROUGHOUT HIS HOSPITALIZATION AND AFTER DISCHARGE. SIX WEEKS POSTOPERATIVELY, THE PATIENT WAS AWAKE AND INTERACTIVE WITH REACTIVE PUPILS, A SYMMETRIC FACE, IN NO DISTRESS, AND OCCASIONALLY PRODUCING A SMILE. UPPER- AND LOWER-EXTREMITY ASHWORTH SCORES WERE 3 AND 4, RESPECTIVELY, WITH THREE BEATS OF CLONUS IN THE LOWER EXTREMITIES. INCISIONS WERE CLEAN, DRY, AND INTACT WITH NEAR RESOLUTION OF THE PREVIOUSLY DISCOLORED AREA OF SKIN WHERE FRICTION AND PRESSURE WERE CONCENTRATED. THE PATIENT HAD BEEN WEANED TO 30 MG OF BACLOFEN AND 0.25 MG OF CLONAZEPAM ADMINISTERED ENTERALLY THREE TIMES DAILY. HIS FAMILY IS CURRENTLY CONTEMPLATING PUMP REIMPLANTATION VERSUS CONTINUING ORAL BACLOFEN THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849519 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Hospitalization| L| R