BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCHROMED II

    MDR report key: 1120546 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04988
    Event Type
    Death
    Date Received
    August 15, 2008
    Date of Event
    July 16, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DIED. THE REPORTER STATED THE "DEATH WAS NOT PUMP RELATED". THE SPECIFIC CAUSE OF DEATH WILL NOT BE DETERMINED UNTIL RESULTS OF TOXICOLOGY AND HISTOLOGY TESTS ARE COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MEDTRONIC PUERTO RICO OPERATIONS CO. 863740 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXPLANTED:| PROGRAMMER MODEL 8840 LOT# UNK| CATHETER MODEL 8731SC LOT# N110192030| IMPLANTED: