BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 820053 · Received February 21, 2007

    Report

    Report Number
    2182207-2007-00627
    Event Type
    Injury
    Date Received
    February 21, 2007
    Date of Event
    January 22, 2007
    Report Date
    January 25, 2007
    Manufacturer
    NEUROLOGICAL DIVISION, METRONIC, INC.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN REPORTED PATIENT HAD A SUCCESSFUL 3 DAY SCREENING TRIAL WITH INTRATHECAL MORPHINE, "EVERYTHING WENT FINE." THE PATIENT WAS LATER IMPLANTED WITH A SYNCHROMED INFUSION SYSTEM, WHICH WAS PROGRAMMED TO DELIVER INTRATHECAL MORPHINE VIA CONTINUOUS INFUSION. LATER THAT SAME DAY, THE PATIENT STARTED COMPLAINING OF ITCHING, AND THE PHYSICIAN REDUCED THE PROGRAMMED PUMP DOSE BY 25%. FOLLOWING THE DOSE REDUCTION THE PATIENT CONDITION IMPROVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AFTER DISCHARGE FROM THE HOSPITAL, THE PATIENT CONTINUED TO EXPERIENCE WORSENING ITCHINESS, INCLUDING ITCHING AT THE SURGICAL SITES, AND TORSO. THE PATIENT PRESENTED TO THE EMERGENCY ROOM FOR FURTHER INTERVENTION, AND DESCRIBED FEELING, "CREEPY, CRAWLY, ANTSY TYPE OF FEELING". THE PHYSICIAN WAS SUSPECTING A DRUG ALLERGY. THE MORPHINE WAS ASPIRATED FROM THE PUMP RESERVOIR, RINSED WITH SALINE AND FILLED WITH FENTANYL AND PROGRAMMED TO DELIVER A DOSE OF 20 MCG/DAY. FOLLOWING THE DRUG CHANGE THE PATIENT'S REPORTED SYMPTOMS CONTINUED, AND NOW INCLUDED NAUSEA. THE PUMP INFUSION MODE WAS STOPPED, AND THE RESERVOIR WAS FILLED WITH PRESERVATIVE FREE NORMAL SALINE. THE PHYSICIAN DISCUSSED WITH MANUFACTURER THE POSSIBILITY OF OBTAINING AN ALLERGY TEST KIT FOR FURTHER PATIENT EVALUATION. THE PHYSICIAN REPORTED THE PATIENT IS ALLERGIC TO PLAVIX AND STATED THAT THE ITCHINESS AND DISCOMFORT WAS SIMILAR TO THE REACTION HE HAD TO PLAVIX. FINAL OUTCOME WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK LKK NEUROLOGICAL DIVISION, METRONIC, INC. 863740AA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R EXPLANTED:| IMPLANTED:| PROGRAMMER MODEL# 8840 N'VISION LOT#: UNKNOWN| INDURA CATHETER MODEL# 8709AA LOT# N090855023