BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1843517 · Received September 22, 2010

    Report

    Report Number
    3007566237-2010-07189
    Event Type
    Injury
    Date Received
    September 22, 2010
    Date of Event
    July 1, 2010
    Report Date
    August 24, 2010
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, PT EXPERIENCED OVERDOSE FOLLOWING PUMP REFILL WITH INCORRECT PROGRAMMING CHANGE. IT WAS NOTED AT REFILL, PT WAS PROGRAMMED AT 24,000 MCG/DAY INSTEAD OF BEING PROGRAMMED AT 2,400 MCG/DAY. THE PT WAS IN THE HOSPITAL. IT WAS NOTED FENTANYL WAS THE PRIMARY DRUG IN THE PUMP. COMPANY REP NOTED, PT WAS FOUND AND HARD TO AROUSE AND THEN WAS TAKEN TO THE EMERGENCY ROOM. THE PT'S PUMP WAS THEN TURNED DOWN BY ANOTHER HCP AND SHE RECOVERED WITHOUT SEQUELAE. IT WAS NOTED, PT STILL HAD THE PUMP AND WAS BEING USED TO CONTROL PAIN. AT THE TIME OF THIS REPORT, NO FURTHER DETAILS WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND WILL BE PROVIDED WHEN AVAILABLE.

    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 54 YR Hospitalization CATHETER: MODEL 8731SC, LOT# N146090013| EXPLANTED:| IMPLANTED: