BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1051732 · Received May 21, 2008

    Report

    Report Number
    3004209178-2008-02688
    Event Type
    Injury
    Date Received
    May 21, 2008
    Date of Event
    April 1, 2008
    Report Date
    April 21, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WENT THROUGH A PUMP REPLACEMENT IN 2008 AND THAT THE PT WAS ADMITTED TO THE HOSPITAL FOR A NON-THERAPY RELATED ISSUE. THE PT'S PUMP WAS REFILLED ON THE FOLLOWING MONTH, AND SOMETIME FOLLOWING THAT THE PT WAS ADMITTED TO THE INTENSIVE CARE UNIT AND PLACED ON A NARCAN DRIP. IT WAS INDICATED THAT THERE HAD BEEN A CHANGE IN THE THERAPY EFFECT. IT WAS UNK IF A PROCEDURE ISSUE CAUSED THE PROBLEM. IT WAS INDICATED THAT THE HEALTH CARE PROVIDERS WERE UNABLE TO ASPIRATE ANYTHING FROM THE PUMP AND THAT THE PUMP WAS REFILLED. THE PUMP CONTAINED LIORESAL, PRIALT AND MORPHINE; CONCENTRATION AND DAILY DOSES BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATHETER MODEL 8703W LOT# L46690| IMPLANTED:| EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK