BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1040512 · Received May 9, 2008

    Report

    Report Number
    6000030-2008-02496
    Event Type
    Injury
    Date Received
    May 9, 2008
    Date of Event
    April 5, 2008
    Report Date
    April 10, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DEVELOPED INCREASED BASELINE SPASTICITY IN THE ABDOMEN AND WITHDRAWAL-TYPE SYMPTOMS FOLLOWING A PUMP REPLACEMENT IN 2008. THE PT WAS GIVEN MULTIPLE THERAPEUTIC BOLUSES WITH NO RELIEF. NO ALARMS WERE HEARD AND THE DRUG PRESCRIPTION WAS CONFIRMED AS ACCURATE. THE PT ALSO HAD A URINARY TRACT INFECTION, LABILE BLOOD PRESSURE, A POSSIBLE BOWEL IMPACTION AND/OR ISCHEMIC BOWEL, AS WELL AS, PNEUMONIA IN THE RIGHT LUNG. THE HCP WAS NOT SURE IF THE SYMPTOMS WERE RELATED TO OTHER MEDICAL ISSUES OR IF IT WAS BECAUSE THE PT WAS NOT GETTING ENOUGH BACLOFEN. THE PT WAS RECEIVING APPROX 450 MCG OF INTRATHECAL BACLOFEN, DAILY. BOTH ELEVATED AND DECREASED WHITE BLOOD CELL COUNTS WERE REPORTED; NO DEVICE TROUBLESHOOTING HAD BEEN DONE BECAUSE OF THIS. THE PHYSICIAN WAS CONCERNED ABOUT DOING ANYTHING INVASIVE SO THE PT WAS BEING TREATED WITH INTRAVENOUS VALIUM "AMONG OTHER THINGS". THE SYMPTOMS OF INCREASED BASELINE SPASTICITY AND WITHDRAWAL BEGAN IN 2008, SUBSIDED ONE DAY LATER, AND RETURNED AGAIN TWO DAYS FOLLOWING. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention IMPLANTED| IMPLANTED| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| EXPLANTED| CATHETER MODEL 8703 LOT# J92098972