BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1030950 · Received April 17, 2008

    Report

    Report Number
    6000030-2008-02019
    Event Type
    Malfunction
    Date Received
    April 17, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 11, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-0022-2007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED AND REPLACED DUE TO EXCEEDING "LONGEVITY" AND THE "PT NOT RECEIVING DRUG." THE PT'S MOTHER NOTED THAT THE PT HAS FELT "STIFF" RECENTLY. THE PUMP CONTAINED LIORESAL 2000 MCG/ML; DAILY DOSE WAS NOT REPORTED. PER THE REPORTER, THERE WAS NO PT INJURY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention IMPLANTED| CATHETER MODEL 8709 LOT# L64777| EXPLANTED