BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 2884110 · Received December 21, 2012

    Report

    Report Number
    3004209178-2012-12191
    Event Type
    Death
    Date Received
    December 21, 2012
    Report Date
    November 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8835, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    HCP REPORTED A PATIENT DEATH. THE PATIENT HAD TERMINAL CANCER, WHICH THE HCP BELIEVED WAS THE CAUSE OF DEATH. THE PUMP WAS REPROGRAMMED THE WEEK PRIOR. HCP JUST REFILLED IT AND THE PATIENT WAS FINE. PER HCP IT WAS INDICATED THAT THE CAUSE OF DEATH WAS NOT DEVICE RELATED. THE PUMP WAS DELIVERING MORPHINE 10 MG/ML AT 3.003 MG/DAY AND BUPIVACAINE 15 MG/ML AT 4.505 MG/DAY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Death