BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1080201 · Received July 22, 2008

    Report

    Report Number
    6000030-2008-04214
    Event Type
    Injury
    Date Received
    July 22, 2008
    Date of Event
    June 1, 2008
    Report Date
    June 22, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED AN INCREASE IN PAIN WITHIN THE LAST REFILL PERIOD. AT RECENT REFILL, THE RESERVOIR VOLUMES WERE AS EXPECTED. THE HCP ORDERED AN MRI TO CHECK FOR GRANULOMA FORMATION AS A PRECAUTION. IT WAS LATER REPORTED THAT AN MRI WAS DONE, BUT THEY WERE UNABLE TO VISUALIZE THE CATHETER IN THE INTRATHECAL SPACE. THE PLAN IS FOR THE PT TO HAVE AN X-RAY TO DETERMINE THE LEVEL OF THE CATHETER THEN THEY WILL ORDER ANOTHER MRI. CURRENTLY, THE PT IS RECEIVING DILAUDID 35 MG/ML AND BUPIVICAINE THROUGH THE PUMP.

    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| CATHETER MODEL 8731 LOT# B008551N11| IMPLANTED:| EXPLANTED,