BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4532337 · Received February 20, 2015

    Report

    Report Number
    3007566237-2015-00425
    Event Type
    Injury
    Date Received
    February 20, 2015
    Report Date
    February 4, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SKALSKY, A.J., FOURNIER, C.M. INTRATHECAL BACLOFEN BOLUS DOSING AND CATHETER TIP PLACEMENT IN PEDIATRIC TONE MANAGEMENT. PHYSICAL MEDICINE AND REHABILITATION CLINICS OF NORTH AMERICA. 2015; 26(1):89-93. DOI: 10.1016/J.PMR.2014.09.011. SUMMARY/REPORTED EVENT: A (B)(6) BOY WITH GROSS MOTOR FUNCTION CLASSIFICATION SYSTEM IV SPASTIC QUADRIPARETIC CEREBRAL PALSY UNDERWENT IMPLANTATION OF AN ITB PUMP. IN THE EARLY POSTOPERATIVE PERIOD, HIS DOSE WAS TITRATED TO 350G PER DAY USING A SIMPLE CONTINUOUS INFUSION. HIS DELIVERY METHOD WAS CHANGED FROM SIMPLE CONTINUOUS INFUSION TO A FLEX DOSING REGIMEN WITH BOLUS ADMINISTRATION EVERY 4 HOURS. BECAUSE THE PUMP BEING USED HAS A MINIMUM BASAL RATE OF 0.002ML PER HOUR OR 4G PER HOUR WHEN USING A 2000G/ML CONCENTRATION, THE 4-HOUR BOLUS DOSE WAS PROGRAMMED TO BE 40G, WHICH MADE THE TOTAL DAILY DOSAGE 335G, A 4.3% REDUCTION IN TOTAL DAILY DOSING. WITHIN 12 HOURS, HE HAD CLEAR SYMPTOMS OF OVERDOSE WITH NAUSEA, VOMITING, LETHARGY, AND CONFUSION BUT UNCHANGED HEART RATE, BLOOD PRESSURE, RESPIRATORY RATE, AND PULSE OXIMETRY MEASUREMENTS. THE BOLUS DOSE WAS DECREASED BY AN ADDITIONAL 25% TO 30G EVERY 4 HOURS WITH A RESULTING TOTAL DAILY DOSAGE OF 275G. OVER THE NEXT 12 HOURS, THERE WAS COMPLETE RESOLUTION OF THE OVERDOSE SYMPTOMS AN D THE RESULTING TONE MANAGEMENT WAS COMPARABLE TO THE ORIGINAL 350G SIMPLE CONTINUOUS INFUSION DESPITE A MORE THAN 20% REDUCTION IN THE TOTAL DAILY DOSAGE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THERE WAS NO CONCERN ABOUT THE DRUG CONCENTRATION SINCE THE PATIENT REMAINED WELL ONCE THE DOSE WAS LOWERED. THE DEVICE SYSTEM REMAINED IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121383 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention