BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3202370 · Received July 2, 2013

    Report

    Report Number
    3004209178-2013-00097
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    March 29, 2012
    Report Date
    March 29, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8840 SERIAL# UNKNOWN; PRODUCT TYPE PROGRAMMER, PHYSICIAN PRODUCT ID 8709SC SERIAL# (B)(4), IMPLANTED: 2011 (B)(6); PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A REFILL, THE PROGRAMMING OF THE PUMP WAS INTERRUPTED. THE CONCENTRATION AND DRUGS IN THE PUMP WERE BEING CHANGED. IN THE MIDDLE OF PROGRAMMING, A ¿SERIOUS ERROR¿ APPEARED AND THE ¿WHOLE THING SHUT DOWN.¿ WHEN THE PUMP WAS INTERROGATED AGAIN, THE NEW CONCENTRATIONS AND DRUGS WERE RECORDED, BUT THE BRIDGE BOLUS WAS NOT BEING PERFORMED. THE PUMP WAS IN ¿STOPPED PUMP¿ MODE. THE PHYSICIAN PLANNED TO REPROGRAM THE OLD DRUG INFORMATION INTO THE PUMP AND THEN REPROGRAM THE PUMP AGAIN TO THE NEW INFORMATION INCLUDING THE BRIDGE BOLUS. THERE WERE NO PATIENT SYMPTOMS. THE DRUGS IN THE PUMP WERE MORPHINE, BACLOFEN, CLONIDINE, AND MARCAINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301001 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR