BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 8628850 · Received May 21, 2019

    Report

    Report Number
    3004209178-2019-10000
    Event Type
    Injury
    Date Received
    May 21, 2019
    Date of Event
    April 18, 2019
    Report Date
    May 21, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    UDI-DI
    00643169630512
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WHO WAS RECEIVING GABLOFEN, 2000 MCG/ML CONCENTRATION AT 279.65 MCG/DAY DOSE VIA INTRATHECAL DRUG DELIVERY PUMP FOR INTRACTABLE SPASTICITY. IT WAS REPORTED THAT PATIENT WAS IN THE PEDIATRIC INTENSIVE CARE UNIT (PICU) SINCE LAST THURSDAY WITH SUSPECTED INTRATHECAL BACLOFEN (ITB) WITHDRAWAL. THIS WAS A DYSTONIC CEREBRAL PALSY (CP) PATIENT WHO HAD A LOT OF BASELINE DYSTONIA AND WAS NON-VERBAL. PATIENT ALSO HAD A FEEDING TUBE. A CATHETER DYE STUDY WAS DONE FRIDAY AND IT WAS NORMAL. THE PATIENT HAD A MILD URINARY TRACTION INFECTION (UTI) THAT WAS TREATED WITH ANTIBIOTICS THROUGH PATIENT'S FEEDING TUBE THURSDAY/FRIDAY. THE HCP WAS UNSURE IF THE UTI WAS CLEARED UP AS THEY HAD NOT DONE ANOTHER CULTURE SINE THE ANTIBIOTIC TREATMENT. ON MONDAY THE PATIENT LOOKED BETTER AND ON TUESDAY PATIENT STILL LOOKED GOOD. AS THEY WERE WEANING THE PATIENT OFF THE ENTERAL BACLOFEN AND INCREASING THE ITB/PUMP/DOSE ON TUESDAY EVENING THE WITHDRAWAL SYMPTOM BEGAN AGAIN. ON WEDNESDAY, A 75 UG BOLUS OVER 3 MIN. WAS PROGRAMMED BUT PATIENT DID NOT RESPOND SO YESTERDAY, VIA THE SIDE PORT THEY MANUALLY PUSHED ITB IN TO THE SPINE 150 UG BOLUS (3 MLS OF 50UG) AND THEN THE PATIENT WAS INTUBATED 3 HOURS LATER. THE PUMP WAS REFILLED 2 WEEKS AGO (APR 11TH) AT THE FACILITY WHERE THE PATIENT LIVED. THEY THEN PROGRAMMED A SINGLE BOLUS OF 150UG OVER 5 MIN. AT 9:30AM AND THE PATIENT DID NOT RESPOND. THE PLAN WAS TO PUT NEW DRUG IN TO THE PUMP RESERVOIR TODAY AND DO A SYSTEM CONTENT REMOVAL PROCEDURE. IF THAT DID NOT MAKE A DIFFERENCE AND THEY RULED OUT THE PUMP BUT THAT IT COULD POSSIBLY BE OR A CATHETER ISSUE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420471 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 00643169630512

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Hospitalization| L