BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1220326 · Received November 4, 2008

    Report

    Report Number
    2182207-2008-07187
    Event Type
    Death
    Date Received
    November 4, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 7, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED. THE REPORT FROM THE CORONER INDICATED THAT THE PATIENT EXPIRED APPROXIMATELY 1 DAY AFTER THE PUMP WAS REFILLED. THE PUMP CONTAINED FENTANYL AND CLONIDINE; CONCENTRATION AND DOSES NOT REPORTED. THE CAUSE OF DEATH OR IF IT WAS DEVICE RELATED WERE UNKNOWN AT THE TIME OF THIS REPORT. THE INVESTIGATION WAS ON-GOING; TOXICOLOGY REPORTS WERE PENDING AT THE TIME OF THE REPORT. IT IS UNKNOWN IF THE DEVICE WOULD BE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE CORONER WAS INQUIRING ABOUT INDEPENDENT PUMP ANALYSIS. THE PATIENT HAD AN IMPLANTED RESTORE SCS SYSTEM AS WELL AS THE INTRATHECAL DRUG PUMP SYSTEM. THE PATIENT WAS REPORTEDLY ON OTHER ORAL PAIN MEDICATIONS, INCLUDING VICODIN, AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CATHETER: MODEL 8711| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 8840