BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1961074 · Received January 12, 2011

    Report

    Report Number
    6000030-2011-00290
    Event Type
    Injury
    Date Received
    January 12, 2011
    Date of Event
    May 5, 2004
    Report Date
    January 6, 2011
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED INCREASED PAIN THAT DID NOT RESPOND TO INCREASES IN HER INTRATHECAL PUMP; INCREASED SWELLING IN HER RIGHT AND LOWER EXTREMITIES CAUSING PAIN; AND MENTAL STATUS CHANGES. THE CATHETER WAS SURGICALLY REPOSITIONED ON (B)(6) 2004. ON (B)(6) 2004, THERAPY WAS ABANDONED. ON (B)(6) 2004, THERAPY WAS RESUMED WITH A CHANGE OF MEDS. THE PT OUTCOME WAS REPORTED AS "RESOLVED WITHOUT SEQUELA". THE DEVICE SYSTEM WAS USED TO DELIVERY MORPHINE SULFATE, BUPIVACAINE, AND COMPOUNDED BACLOFEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG 8327L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other IMPLANTED:| CATHETER: MODEL 8709, LOT# J11760R01| EXPLANTED: