BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3201497 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00416
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Report Date
    January 30, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, LOT# N183264002, IMPLANTED: 2009-(B)(6), PRODUCT TYPE CATHETER PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: 2006-(B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED AS OF DECEMBER 2008 THE PUMP WAS BEING USED TO DELIVER COMPOUNDED BACLOFEN. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD TWO MALFUNCTIONS ON HER PUMP. IT WAS NOTED THAT IT WAS ¿IN THE AREA THAT THEY JUST DON¿T SEE EVER MALFUNCTIONS BEFORE,¿ AND ¿IT¿ DIDN¿T SHOW UP ON ANY OF THE TESTS. THIS EVENT OCCURRED ABOUT FOUR YEARS PRIOR TO THE DATE OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301694 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 863740

    Patients

    Seq Age Sex Outcome Treatment
    1 00017 YR