BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ESYNCHROMED II

    MDR report key: 2182302 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05279
    Event Type
    Malfunction
    Date Received
    July 11, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN WAS NOT ABLE TO ASPIRATE ANYTHING BACK FROM CATHETER AND USED SMALL SYRINGE AND ALSO CAP TO TRY TO ASPIRATE. PHYSICIAN DECIDED NOT TO REVISE THE CATHETER, 20 CM OF CATHETER WAS REMOVED. HOWEVER, NO DRUG CAME OUT OF THAT SECTION EITHER. THE 2000 MCG/ML DRUG WAS IN THE CATHETER AND THE PUMP WAS FILLED WITH 500 MCG/CL, I.E. THE RESERVOIR. THERE WERE CONCERNS THAT THERE WAS DRUG IN CATHETER, WATER IN PUMP TUBING AND DRUG IN RESERVOIR. LATER, IT WAS REPORTED THAT THE PRIMING BOLUS WAS SET AT .124 FOR TOTAL CATHETER VOLUME, A 50 MCG BOLUS WAS PROGRAMMED WHEN PUMP WAS AT 2000 CONCENTRATION FOR A DURATION OF 8 HOURS. IT WAS REVIEWED THAT THE PT WOULD BE GETTING WATER FOR ROUGHLY 3.5 - 6 HOURS, AND THEY MIGHT BOLUS WATER IN 8 HOURS. THERE WERE CONCERNS WITH PROGRAMMING NOT BEING PRECISE DUE TO PUMP TUBING VOLUMES. THE DRUG STATUS WAS AS FOLLOWS: STERILE WATER STATUS NEW, BACLOFEN CONC. 2000, DOSE 597, STATUS CURRENT AND BACLOFEN CONC. 500, DOSE 597 STATUS NEW. POST-OPERATIVE PRIMING, THE PT WAS DOING FINE AND WAS BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ESYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR EXPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 863720,| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# J12260R35| EXPLANTED:| LOT# NGP009235N