BEUDAMED
    FDA Adverse Event Death Summary report: N

    PETITE PACING LEAD

    MDR report key: 712922 · Received April 25, 2006

    Report

    Report Number
    1035166-2006-00015
    Event Type
    Death
    Date Received
    April 25, 2006
    Date of Event
    March 12, 2006
    Report Date
    April 24, 2006
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT PASSED AWAY 3/12/2006; THE COMBINATION OF EVNTS THAT WERE REPORTED MAY HAVE CAUSED AN ELECTROCUTION. THE CORONER PUT THE DECEASE MAN ON A CARDIAC MONITOR UPON ARRIVAL AND FOUND THAT THE PACEMAKER WAS NOT FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PETITE PACING LEAD PASSIVE FIXATION PACING LEAD DTB OSCOR INC. PETITE58RB 5W3

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death