BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 1231163 · Received November 12, 2008

    Report

    Report Number
    6000030-2008-07385
    Event Type
    Malfunction
    Date Received
    November 12, 2008
    Date of Event
    October 2, 2008
    Report Date
    October 16, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE NURSE NOTICED INCREASED FLUID AND SWELLING AROUND THE POCKET. THE PT WAS OTHERWISE ASYMPTOMATIC. AN X-RAY WAS DONE WHICH SHOWED THE PUMP HAD FLIPPED IN THE POCKET, AND THE CATHETER HAD DISLODGED. A CATHETER ACCESS PORT STUDY (PERFORMED IN 2008) CONFIRMED A DISCONNECTED CATHETER. AS THE PT DID NOT REPORT A CHANGE IN SYMPTOMS, THE DECISION WAS MADE TO EXPLANT THE PUMP. THE DRUG USED IN THE PUMP WAS BUPIVICAINE 0.125% AT A DOSE OF 2 MG/DAY. THE PUMP AND CATHETER WERE EXPLANTED AND DISCARDED IN 2008. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709| PROGRAMMER: MODEL PROGRAMMER