BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1051288 · Received May 21, 2008

    Report

    Report Number
    3004209178-2008-02689
    Event Type
    Death
    Date Received
    May 21, 2008
    Date of Event
    February 17, 2008
    Report Date
    June 7, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PT'S PUMP HAS BEEN ROUTINELY FILLED WITH DILAUDID AND MORPHINE. THESE MEDICATIONS CONTROLLED THE BACK AND FOOT PAIN. THE PT PLANNED TO CHANGE HEALTH PROFESSIONAL. THE PUMP WAS LAST REFILLED IN 2008. THE MEDICATION USED AT THIS REFILL IS UNK. THE REFILL WAS ENOUGH FOR ONE MONTH. SINCE THEN, THE PT EXPERIENCED TENDERNESS AT THE PUMP SITE, SEVERE PAIN IN HIS BACK AND LEFT FOOT FELT LIKE IT WAS ON FIRE (SIDE USED FOR BYPASS GRAFT). HE WAS ALSO FEELING UNEASY AND SHAKING WHILE SLEEPING. NO NAUSEA OR VOMITING WAS REPORTED. HE DID NOT GET OUT OF BED, EXCEPT TO THE BATHROOM, FOR A WEEK. THE PT DIED APPROX ONE MONTH AFTER THE REFILL. THE PT HAD NOT FOUND A NEW HEALTH PROFESSIONAL. THE CAUSE OF DEATH WAS UNK. IT WAS NOT BELIEVED TO BE DEVICE RELATED. ATTEMPTS TO OBTAIN ADD'L INFO WERE UNSUCCESSFUL. IT IS UNK IF AN AUTOPSY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863720 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death CATHETER MODEL 8709 LOT# N107661014| PROGRAMMER MODEL 8840 LOT# UNK| EXPLANTED| IMPLANTED