BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED EL

    MDR report key: 1672723 · Received April 30, 2010

    Report

    Report Number
    6000030-2010-03557
    Event Type
    Death
    Date Received
    April 30, 2010
    Date of Event
    April 1, 2010
    Report Date
    April 2, 2010
    Manufacturer
    RICE CREEK MANUFACTURING
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4)

    Description of Event or Problem · 1

    THE PT'S DEATH WAS REPORTED. THE PT DIED IN THE CITY OF (B) (6), (B) (6). THE CAUSE OF DEATH WAS UNK. THE CAUSE OF DEATH WAS MEDTRONIC DEVICE-RELATED. MEDTRONIC WAS NOT INVOLVED IN TROUBLESHOOTING THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Death CATHETER: MODEL 8709, LOT# UK6112246| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| IMPLANTED: