BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1242895 · Received November 21, 2008

    Report

    Report Number
    3004209178-2008-07667
    Event Type
    Death
    Date Received
    November 21, 2008
    Date of Event
    October 22, 2008
    Report Date
    October 27, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPIRED. THE CAUSE OF DEATH WAS NOT REPORTED. THE PT'S DIAGNOSES INCLUDED METASTATIC BREAST CANCER. THE REPORT INDICATED THAT THE DEATH WAS UNRELATED TO THE IMPLANTED DEVICE SYSTEM. THE PUMP WAS USED TO DELIVER HYDROMORPHONE 2.0 MG/ML WITH A DAILY DOSE OF 0.2502MG. THE PUMP ALSO CONTAINED COMPOUNDED BACLOFEN 250 MCG/ML AND DROPERIDOL 200 UG/ML.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 8637-40 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death EXPLANTED:| CATHETER: MODEL 8709| IMPLANTED:| PROGRAMMER: MODEL 8832| PROGRAMMER: MODEL 8840