BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1211061 · Received October 24, 2008

    Report

    Report Number
    6000030-2008-06879
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 24, 2008
    Report Date
    September 24, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT PRESENTED IN 2008, WITH SYMPTOMS OF WITHDRAWAL, INCLUDING INCREASED TONE IN UPPER EXTREMITIES. THE PT WAS GIVEN PROGRAMMED BOLUSES THROUGH THE PUMP AND EVALUATED AT THE CLINIC WITH NO CHANGES IN RELIEF. A DECISION WAS MADE TO REPLACE THE PUMP DUE TO ITS AGE (SURGERY WAS A WEEK LATER). WHEN THE SURGEON DISCONNECTED THE CATHETER FROM THE PUMP, THERE WAS A BRISK RETROGRADE FLOW OF CEREBROSPINAL FLUID NOTED; THE CATHETER WAS LEFT IN PLACE. IT WAS ALSO NOTED ON THE FOLLOWING MONTH, THAT THE PUMP WAS PROGRAMMED TO INFUSE A BOLUS AFTER THE CATHETER WAS DISCONNECTED AND DROPLETS OF MEDICATION WAS SEEN AT THE TIP OF THE PUMP. AS OF THE SAME DAY, THE PT'S STATUS WAS NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8626 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention EXPLANTED:| IMPLANTED:| PROGRAMMER| CATHETER MODEL 8711