BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1082988 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04445
    Event Type
    Injury
    Date Received
    July 28, 2008
    Date of Event
    January 1, 2008
    Report Date
    June 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT MISSED HIS REFILL VISIT AND THE PUMP RAN EMPTY. WHEN THE PT CAME IN FOR REFILL, SOMEHOW PRESSURE BACKED UP FROM THE PUMP AND THE MEDICATION WAS INJECTED AROUND THE PUMP PORT. THE MEDICATION WAS WITHDRAWN IMMEDIATELY. THE PT WAS OBSERVED IN THE HOSPITAL FOR 24 HOURS; THE PT EXPERIENCED SOMNOLENCE. THE PT OUTCOME WAS REPORTED AS "NO INJURY". THE PUMP WAS USED TO DELIVER MORPHINE.

    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 EXPLANTED| PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL 8711 LOT # J0056636R| IMPLANTED