BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 3910180 · Received July 2, 2014

    Report

    Report Number
    6000030-2014-00089
    Event Type
    Malfunction
    Date Received
    July 2, 2014
    Report Date
    June 13, 2014
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8709, LOT# J10901R37, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PUMP ¿TURNED UPSIDE DOWN AND THEY CAN¿T GET IT TO TURN OVER.¿ PER THE PATIENT THE PUMP WAS OUTDATED AND THEY WANTED TO REPLACE IT. THE PATIENT STATED IT WAS NOTICED IN ¿LIKE 2003/2004¿ THE PUMP ¿TURNED UPSIDE DOWN¿. THE PATIENT STATED ¿I WAS GETTING 100% AND I DON¿T LIKE 10-15 AT A TIME¿ IN REGARDS TO DRUG INFORMATION AT THAT TIME. THE PUMP HAD BEEN USED TO DELIVER MORPHINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386463 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR