BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION PUMP

    MDR report key: 2931551 · Received January 28, 2013

    Report

    Report Number
    3007566237-2013-00294
    Event Type
    Injury
    Date Received
    January 28, 2013
    Report Date
    January 9, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH (INTRAVENTRICULAR), SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER: PRODUCT ID NEU_UNKNOWN_CATH (INTRATHECAL), SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH A PREVIOUSLY REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    HENRY-SOCHA, N., ALDAHONDO, N., KIM, P. D., KRACH, E. UNUSUAL COMPLICATION OF INTRATHECAL BACLOFEN PUMP AND CATHETER PLACEMENT IN AC HILD WITH CEREBRAL PALSY: A CASE REPORT. PM AND R. 2012;4(10):S343. SUMMARY/REPORTED EVENT: A (B)(6) BOY WITH MIXED TONE QUADRIPLEGIC CEREBRAL PALSY PRESENTED DUE TO CONCERNS OF A MALFUNCTIONING INTRAVENTRICULAR BACLOFEN PUMP WITH WORSENING TONE DESPITE INCREASED INTRAVENTRICULAR DOSE TO NEARLY 2000 MCG/DAY, ORAL BACLOFEN, AND VALIUM. HE WAS FOUND TO HAVE HYDROCEPHALUS FOR WHICH A VENTRICULOPERITONEAL SHUNT WAS PLACED. IN ADDITION, THE INTRAVENTRICULAR BACLOFEN CATHETER WAS REMOVED AND ONE PLACED INTRATHECALLY. THE PROCEDURE WAS CHARACTERIZED BY SIGNIFICANT DIFFICULTY THREADING THE CATHETER INTO THE INTRATHECAL SPACE REQUIRING SEVERAL ATTEMPTS. IMMEDIATELY POST-OPERATIVELY, TONE WAS WELL CONTROLLED WITH A LOWER INTRATHECAL BACLOFEN (ITB) DOSE (800 MCG/DAY); HOWEVER, HE REQUIRED FURTHER DOSE ADJUSTMENTS TO 1800 MCG/DAY FLEX DOSING IN ADDITION TO ORAL TIZANIDINE AND VALIUM WITH POOR TONE CONTROL, RAISING CONCERNS FOR CATHETER MALFUNCTION. A DYE STUDY WAS TERMINATED EARLY DUE TO DIFFICULTY ASPIRATING FROM THE CATHETER ACCESS PORT. A COMPUTED TOMOGRAPHY (CT) MYELOGRAM REVEALED THE CATHETER ENTERING THE SPINE EPIDURALLY AT THE LUMBAR LEVEL AND THREADED UP TO THE THORACIC SPINE IN THE EPIDURAL SPACE. REVISION OF THE ITB CATHETER WAS DONE VIA LUMBAR LAMINECTOMY TO VERIFY INTRATHECAL PLACEMENT. ITB DOSE WAS 650 MCG/DAY SIMPLE CONTINUOUS AT THE TIME OF DISCHARGE WITH MUCH BETTER TONE CONTROL. ADDITIONAL INFORMATION IS BEING REQUESTED AT THIS TIME; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36787 INFUSION PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION NEU_UNKNOWN_PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 00010 YR Required Intervention