BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1192085 · Received October 7, 2008

    Report

    Report Number
    6000030-2008-06394
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 12, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS EXPERIENCING NAUSEA, VOMITING AND A RETURN OF SYMPTOMS FOLLOWING A FALL. THE PATIENT HAD FALLEN (DATE OF FALL UNKNOWN) CAUSING A HEMATOMA. THE HEMATOMA REQUIRED INTERVENTION TO DRAW OFF THE BLOOD. A BACK INJURY WAS SUSPECTED DUE TO THE FALL. TROUBLESHOOTING WAS BEING CONSIDERED FOR THE CATHETER. THE DRUG USED IN THE PUMP WAS NOT REPORTED. A REVISION SURGERY WAS SCHEDULED WITH THE PLAN TO REVISE THE CATHETER AND POSSIBLY REPLACE THE PUMP AT THE SAME TIME SINCE IT HAD BEEN IN PLACE FOR SEVEN YEARS. THE MANUFACTURER'S DEVICE TRACKING SYSTEM INDICATED BOTH THE PUMP AND CATHETER WERE REPLACED APPROXIMATELY TWO WEEKS LATER. THE PATIENT OUTCOME REMAINS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| CATHETER MODEL 8709 LOT# J10852R31| IMPLANTED