BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 1663369 · Received April 19, 2010

    Report

    Report Number
    6000030-2010-03138
    Event Type
    Death
    Date Received
    April 19, 2010
    Date of Event
    November 28, 2009
    Report Date
    March 23, 2010
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) - THE PUMP AND CATHETER HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE DEVICE WAS RETURNED TO THE MFR; THE RETURN PAPERWORK STATED "HUMAN REMAINS". THE DEVICE TRACKING SYS INDICATED THE PT HAD EXPIRED. THE RELATIONSHIP OF THE DEVICE SYSTEM TO THE PT'S DEATH WAS UNK. NO OTHER INFO WAS PROVIDED AT THE TIME OF THIS REPORT. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL LKK RICE CREEK MFG 8627-18 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death EXPLANTED:| CATHETER: MODEL 8703W, LOT# L48429| PROGRAMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED: