BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1082995 · Received July 28, 2008

    Report

    Report Number
    6000030-2008-04449
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 30, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1149-2008
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED NEW ONSET OF WEAKNESS AND NUMBNESS. THE PT WAS ADMITTED TO THE HOSPITAL IN 2008. A CT SCAN WAS PERFORMED, BUT RESULTS WERE NOT AVAILABLE. THE PT WAS CONCERNED ABOUT A GRANULOMA. THE PUMP WAS USED TO DELIVER MORPHINE 50MG/ML AND FENTANYL 50 MCG/ML. ADD'L INFO HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATHETER MODEL #: 8709 LOT#: J11528R48| PROGRAMMER MODEL PROGRAMMER LOT #UNK| IMPLANTED| EXPLANTED