BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 1060660 · Received June 13, 2008

    Report

    Report Number
    2182207-2008-03249
    Event Type
    Injury
    Date Received
    June 13, 2008
    Date of Event
    May 1, 2008
    Report Date
    May 15, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT WAS EXPERIENCING NAUSEA, SEDATION, CHILLS AND HOT FLASHES FOLLOWING A REFILL THE WEEK BEFORE. THE MEDICATION USED IN THE PUMP WAS CHANGED FROM MORPHINE AND ANOTHER UNK DRUG TO DILAUDID DURING THE REFILL. ADD'L INFO HAS BEEN REQUESTED FROM THE HEALTH CARE PROFESSIONAL, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC NEUROMODULATION 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXPLANTED| IMPLANTED| CATHETER MODEL 8709 LOT# N092227017| PROGRAMMER MODEL 8840 LOT#UNK