BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1192075 · Received October 7, 2008

    Report

    Report Number
    6000030-2008-06388
    Event Type
    Injury
    Date Received
    October 7, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 11, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0745-2008
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS BEEN RETURNED TO THE MFR FOR ANALYSIS, WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    THE PT WAS SHOWING UNSPECIFIED WITHDRAWAL SYMPTOMS. THE PUMP VOLUMES WERE CHECKED AND THE ASPIRATED VOLUME DID NOT MATCH THE CALCULATED VOLUME; THE SPECIFIC VOLUMES WERE NOT REPORTED. A ROTOR TEST (DATE NOT REPORTED) SHOWED NO MOTOR-FUNCTION. THE PUMP WAS REPLACED. THERE WAS NO PT INJURY. FOLLOWING THE REPLACEMENT, THE INTRATHECAL BACLOFEN THERAPY WAS RESTORED. THE PT WAS WELL. THE PUMP WAS USED TO DELIVER LIORESAL (2000 MCG/ML).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention