BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4133196 · Received October 1, 2014

    Report

    Report Number
    3007566237-2014-02798
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 12, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO MATCH THIS EVENT WITH ANY PREVIOUSLY REPORTED EVENT. CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_CATH, LOT# UNKNOWN, PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    MAINO, P., KOETSIER, E., PEREZ, R.S. FENTANYL OVERDOSE CAUSED BY MALFUNCTION OF SYNCHROMED II INTRATHECAL PUMP: TWO CASE REPORTS. RE GIONAL ANESTHESIA AND PAIN MEDICINE. 2014; 39(5):434-437. DOI: 10.1097/AAP.0000000000000132 SUMMARY: INTRATHECAL DRUG DELIVERY SYSTEMS ARE USED TO TREAT PATIENTS WITH CHRONIC REFRACTORY PAIN SYNDROMES AND SPASTICITY. THE OBJECTIVE OF OUR CASE REPORT WAS TO DEMONSTRATE THAT INTRATHECAL PUMP MALFUNCTION CAN LEAD TO INTRATHECAL OVERDOSING OF DRUGS. TWO CASES OF FENTANYL OVERDOSE DUE TO INTRATHECAL PUMP MALFUNCTIONS THAT LED TO OVERINFUSION ARE PRESENTED. REPORTED EVENT: A 47-YEAR-OLD WHITE WOMAN WAS IMPLANTED IN MARCH 2008 WITH A SYNCHROMED II PROGRAMMABLE PUMP FOR INTRACTABLE DISCOGENIC PAIN. AT THE TIME OF A REGULAR REFILL PROCEDURE IN MAY 2013, THE PUMP CONTAINED FENTANYL 6 MG/ML AND THE INFUSION RATE WAS 3100 ¿G (0.52 ML) PER DAY. THE PATIENT REPORTED NOT BEING AWARE OF ANY SYMPTOMS OF OVERDOSE OR WITHDRAWAL IN THE LATEST PERIOD. NO MEDICATION COULD BE ASPIRATED FROM THE RESERVOIR, ALTHOUGH THE TELEMETRIC PROGRAMMER HAD INDICATED AN EXPECTED RESIDUAL VOLUME OF 5 ML. THE PUMP WAS REFILLED WITH A FENTANYL SOLUTION OF THE SAME CONCENTRATION. THE PHYSICIAN, ALERTED FOR A POSSIBLE OVERRUNNING PUMP, REDUCED THE RATE OF FENTANYL FROM 3100 TO 2700 ¿G/D AND MARKED TO RECHECK THE RESIDUAL VOLUMES PRECISELY AT THE NEXT REFILL. THE REFILL PROCEDURE WAS UNEVENTFUL, AND THE PATIENT LEFT OUR HOSPITAL 30 MINUTES AFTER THE PROCEDURE WITH NO INDICATION OF ANY PROBLEM. FIVE HOURS AFTER THE REFILL, THE PATIENT STARTED TO FILL DIZZY, AND 10 HOURS AFTER THE REFILL, SHE WAS FOUND UNRESPONSIVE BY HER HUSBAND. THE PARAMEDICS FOUND THE PATIENT IN A COMATOSE STATE WITH A GLASGOW COMA SCORE OF 3 AND PINPOINT PUPILS WITH FAINT REACTION TO LIGHT. A FENTANYL OVERDOSE WAS SUSPECTED AND THE PARAMEDICS ADMINISTERED 0.4 MG OF NALOXONE. THE PATIENT AWAKENED IMMEDIATELY AND THE GLASGOW COMA SCORE WENT UP TO 14. SHE WAS ADMITTED TO THE INTENSIVE CARE UNIT WITH A CONTINUOUS INFUSION OF NALOXONE 1.6 MG/H INTRAVENOUSLY. THE INTRATHECAL PUMP WAS IMMEDIATELY EMPTIED. A 16 ML OF FENTANYL WAS ASPIRATED INSTEAD OF THE EXPECTED 19.6 ML, AND THEREFORE, 21,600 ¿G OF FENTANYL WERE MISSING FROM THE RESERVOIR. OVERINFUSION WAS SUSPECTED, AND THE RESERVOIR WAS REFILLED WITH SALINE AND SET ON MINIMAL FLOW RATE. A URINE SCREENING TEST (MULTI DRUG OF ABUSE URINE TEST) PERFORMED WAS NEGATIVE FOR OPIOIDS, BUT LATER IT WAS DETERMINED THAT THIS TEST WAS NOT SUITABLE FOR DETECTING FENTANYL. THE PATIENT RECOVERED COMPLETELY IN 2 DAYS. THE PUMP WAS REMOVED AND NOT REPLACED. THE PUMP WAS SENT TO THE MANUFACTURER FOR ANALYSIS. A REVIEW OF THE PUMP¿S INTERROGATION REPORT CONFIRMED THAT THE MOTOR HAD A HARD STALL. INTERNAL INSPECTION OF THE PUMP MOTOR COMPARTMENT REVEALED SIGNIFICANT RESIDUE, A LOT OF MOISTURE, AND SEVERE CORROSION OF THE MOTOR GEAR ASSEMBLY. THE INNER TUBING OF THE PUMP WAS BREACHED AND SHOWED A LOT OF WEARING AND RIGIDITY. THE CONDITION OF THE INNER TUBING MADE IT POSSIBLE THAT DRUG HAD LEAKED INTO TO THE PUMP, WHICH HAD CAUSED THE CORROSION. THIS CORROSION MIGHT HAVE RESULTED IN A MOTOR STALL. THE RIGIDITY OF THE INNER TUBING LIKELY RESULTED IN THE TUBING NOT RUNNING SMOOTHLY OVER THE ROLLER ARMS AND MAKING SPURTS. ACCORDING TO THE MANUFACTURER¿S ANALYSIS, THIS COULD HAVE CAUSED THE OVERINFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611614 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Hospitalization| L| R