BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 1032781 · Received April 23, 2008

    Report

    Report Number
    6000030-2008-02141
    Event Type
    Injury
    Date Received
    April 23, 2008
    Date of Event
    June 26, 2006
    Report Date
    November 3, 2006
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    PT REPORTS PUMP WAS EXPLANTED DUE TO STAFF INFECTION AND FAILURE. ALSO INDICATED EXPERIENCED WITHDRAWAL FOR TWO WEEKS FOLLOWING PUMP IMPLANT. PT'S WIFE STATES PT DEVELOPED STAFF INFECTION STARTING AT POCKET ABOUT 3-5 DAYS AFTER THE 1ST REFILL. DRUG USED IN PUMP WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATHETER MODEL 8709AA| PROGRAMMER