BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1051463 · Received May 21, 2008

    Report

    Report Number
    6000030-2008-02680
    Event Type
    Malfunction
    Date Received
    May 21, 2008
    Date of Event
    April 15, 2008
    Report Date
    April 21, 2008
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT'S INTRATHECAL DRUG DELIVERY PUMP WAS EXPLANTED AND REPLACED DUE TO UNDERINFUSION. THE PT WAS EXPERIENCING PAIN AND SPASTICITY PRIOR TO REFILL. THE DRUG USED IN THE PUMP WAS A MIXTURE OF MORPHINE SULFATE 13.0 MG/ML AND COMPOUNDED BACLOFEN 2000 MCG/ML AT A DOSE OF 4.282 MG/DAY. THE PT RECOVERED WITHOUT SEQUELA FOLLOWING REPLACEMENT. ADD'L INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 35 YR Required Intervention CATHETER MODEL 8709 LOT# J11434R57| PROGRAMMER MODEL PROGRAMMER LOT# UNK| EXPLANTED| IMPLANTED