BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2993205 · Received March 7, 2013

    Report

    Report Number
    3004209178-2013-03456
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PHYSICIAN PROGRAMMER, MODEL 8840, LOT# UNKNOWN, IMPLANTED:NA, EXPLANTED: NA; CATHETER, MODEL 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    THE DAY BEFORE THE REPORT THE DEVICE WAS REFILLED WITH A NEW CONCENTRATION. A BRIDGE BOLUS WAS NOT PERFORMED AND THE OLD CONCENTRATION AND DOSE WERE LEFT THE SAME. THERE WERE NO PATIENT SYMPTOMS AS THE NEW CONCENTRATION HAD NOT YET REACHED THE PATIENT . THE PATIENT WENT BACK TO THE CLINIC THE NEXT DAY, 25 HOURS AFTER REFILL, AN "ADJUSTED" BRIDGE WAS CALCULATED AND PROGRAMMED TO ENSURE OLD CONCENTRATION WAS SAFELY DELIVERED. THE DEVICE SYSTEM WAS USED TO INFUSE CLONIDINE BACLOFEN (COMPOUNDED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97825 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1