BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN

    MDR report key: 1353061 · Received March 30, 2009

    Report

    Report Number
    2182207-2009-02192
    Event Type
    Injury
    Date Received
    March 30, 2009
    Date of Event
    January 1, 2008
    Report Date
    February 23, 2009
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    LITERATURE: FERNANDES P, DOLAN L. WEINSTEIN SL. INTRATHECAL BACLOFEN WITHDRAWAL SYNDROME FOLLOWING POSTERIOR SPINAL FUSION FOR NEUROMUSCULAR SCOLIOSIS: A CASE REPORT. IOWA ORTHOP J. 2008; 28: 77-80. SUMMARY: THE PURPOSE OF THIS STUDY IS TO RAISE PHYSICIAN AWARENESS OF INTRATHECAL BACLOFEN WITHDRAWAL SYMPTOMS. TWO DAYS FOLLOWING SPINAL FUSION SURGERY, THE PATIENT HAD AN ABRUPT ONSET OF MULTIPLE SYMPTOMS OF DELIRIUM, INCLUDING FLUCTUATING LEVELS OF AWARENESS AND ORIENTATION AND HALLUCINATIONS. BLOOD AND METABOLIC WORKUP WAS NORMAL. SHE WAS ON HYDROMORPHONE, MORPHINE, CODEINE, ACETAMINOPHEN, DIPHENHYDRAMINE AND PROMETHAZINE. MORPHINE WAS DISCONTINUED BECAUSE SYMPTOMS WERE BELIEVED TO BE DRUG-RELATED DELIRIUM. PATIENT HAD INCREASED SPASTICITY, VISUAL HALLUCINATIONS, AND SLEEP DISTURBANCE. THREE DAYS POSTOPERATIVE, HYDROMORPHONE, CODEINE AND DIPHENHYDRAMINE WAS DISCONTINUED AND PATIENT WAS SWITCHED TO ORAL ACETAMINOPHEN AND AMBIEN. FOUR DAYS POSTOPERATIVE, A PEDIATRIC PSYCHIATRY CONSULTATION SUGGESTED ITB WITHDRAWAL. TELEMETRICS RULED OUT PUMP MALFUNCTION. RADIONUCLIDE WAS USED TO FILL THE RESERVOIR AND A SIGNIFICANT ACCUMULATION OF THE ISOTOPE TRACER WAS REVEALED OUTSIDE THE SPINAL CANAL BY SCINTIGRAM. SYMPTOMS WERE REPORTED, MOST LIKELY, AS BACLOFEN WITHDRAWAL SYNDROME DUE TO CATHETER LEAK. ORAL BACLOFEN WAS STARTED TO 60 MG/DAY AND HALOPERIDOL WAS STARTED WITH RESOLUTION OF SYMPTOMS WITHIN 72 HOURS. PATIENT WAS DISCHARGED ON DAY EIGHT AND KEPT ON ORAL BACLOFEN UNTIL SIX MONTHS POSTOPERATIVE WHEN THE CATHETER WAS REVISED. SEE MANUFACTURER REPORT NUMBER: 2182207200902180.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN LKK MEDTRONIC NEUROMODULATION PUMP NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Hospitalization| R EXPLANTED:| EXPLANTED:| CATHETER: MODEL CATHETER| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER| IMPLANTED: