BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1120753 · Received August 15, 2008

    Report

    Report Number
    2182207-2008-04959
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 17, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS INADVERTENTLY BOLUSED AFTER THE PUMP TUBING WAS PRIMED. DURING SURGERY, THE CATHETER HAD BEEN DRIPPING CONTINUOUSLY FOR APPROX 20 MINUTES WITH WHAT WAS THOUGHT TO BE CEREBROSPINAL FLUID PRIOR TO CONNECTION TO THE PUMP. THE SURGERY WAS PROLONGED AS THE DRUG WAS NOT AVAILABLE DURING THE CASE. THE MEDICATION WAS PUT INTO THE PUMP AND THEN THE PUMP WAS CONNECTED TO THE EXISTING CATHETER. THE HCP LEFT THE PUMP AS IT WAS PROGRAMMED AND DID NOT ASPIRATE FROM THE CATHETER ACCESS PORT. IT WAS ESTIMATED THAT THE PT RECEIVED APPROX 2 MG OVER 12 MINUTES; THE DAILY DOSE WAS LESS THAN 1 MG. THE PUMP CONTAINED MORPHINE IN AN UNK CONCENTRATION. THE PT WAS ALERT WITH STABLE VITAL SIGNS AND REMAINED IN THE RECOVER ROOM FOR OBSERVATION. THE HCP ASPIRATED 30-40 MLS FROM THE CATHETER ACCESS PORT TO LOWER THE MORPHINE CONCENTRATION IN THE CEREBROSPINAL FLUID. THE PT WAS SUBSEQUENTLY ADMITTED TO THE HOSP AND DISCHARGED THE FOLLOWING DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 8637 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R EXPLANTED| CATHETER MODEL 8709 LOT # J0058224R| PROGRAMMER MODEL 8840 LOT # UNK| IMPLANTED