BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 1031292 · Received April 18, 2008

    Report

    Report Number
    6000030-2008-02078
    Event Type
    Death
    Date Received
    April 18, 2008
    Date of Event
    March 10, 2007
    Report Date
    March 19, 2008
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT UNDERWENT A SURGICAL PROCEDURE IN 2007, IN WHICH THE PUMP WAS IMPLANTED. ON THE SAME DAY, SHE WAS DISCHARGED TO THE CARE OF HER HUSBAND WHO PUT HER TO BED TO REST. AT APPROX 1:00 AM THE NEXT DAY, THE HUSBAND CHECKED ON HIS WIFE AND FOUND SHE HAD DIED. THE TOXICOLOGY SAMPLES WERE LOST BY THE CORONER'S OFFICE, SO CAUSE OF DEATH WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MANUFACTURING 8627L18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death PROGRAMMER MODEL PROGRAMMER LOT#UNK| EXPLANTED| IMPLANTED| IMPLANTED| EXPLANTED| CATHETER MODEL 8709 LOT #N064780007