BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 4133180 · Received October 1, 2014

    Report

    Report Number
    3007566237-2014-02797
    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 44-YEAR-OLD WHITE WOMAN EXPERIENCING CHRONIC INTRACTABLE LUMBAR BACK PAIN WAS IMPLANTED IN SEPTEMBER 2006 WITH A SYNCHROMED II PROGRAMMABLE PUMP. IN MAY 2011, SHE INFORMED US THAT SHE FELT MUCH SLEEPIER AND NOTICED A SIGNIFICANT PAIN REDUCTION IN THE LAST WEEKS. NO AUGMENTATION HAD TAKEN PLACE IN THE LAST MONTHS. THE PUMP CONTAINED FENTANYL 3 MG/ML AND THE INFUSION RATE WAS 1740 ¿G (0.58 ML) PER DAY. ACCORDING TO STANDARD PRACTICE, WE EMPTIED THE RESIDUAL VOLUME OF THE RESERVOIR BEFORE REFILLING IT WITH THE NEW SOLUTION. ALTHOUGH THE TELEMETRIC PROGRAMMER HAD INDICATED THAT THE PUMP WAS EXPECTED TO HAVE 21.8 ML OF FENTANYL LEFT IN THE RESERVOIR, ONLY 12.5 ML OF FENTANYL WAS ASPIRATED. SIX DAYS LATER, THE IDDS WAS SURGICALLY REMOVED BECAUSE OF SUSPICION OF OVERINFUSION. THE REMOVED SYNCHROMED II PUMP WAS SENT TO THE MANUFACTURER FOR ANALYSIS AND DISPENSE TESTING REVEALED THAT THE PUMP WAS OVERINFUSING. INTERNAL INSPECTION OF THE PUMP MOTOR COMPARTMENT SHOWED THAT A SIGNIFICANT AMOUNT OF DRUG PRECIPITANT WAS PRESENT IN THE PUMP HEAD AND IN THE PUMP TUBE COMPARTMENTS. THE INNER TUBING OF THE PUMP HAD A SIGNIFICANT AMOUNT OF PRECIPITANT DEPOSITED ON IT PREVENTING THE TUBE FROM OCCLUDING PROPERLY. ACCORDING TO THE ANALYSIS, THIS INSUFFICIENT TUBE OCCLUSION WAS THE MOST LIKELY CAUSE OF THE OVERINFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    611163 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention