BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPINAL PAK

    MDR report key: 538432 · Received August 9, 2004

    Report

    Report Number
    2242816-2004-00010
    Event Type
    Death
    Date Received
    August 9, 2004
    Report Date
    August 6, 2004
    Manufacturer
    EBI, LP
    Product Code
    LOE
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    EBI HAS BEEN NOTIFIED VIA E-MAIL OF THE DEATH OF ONE OF ITS SPINALPAK PTS. THE PT HAD A DEFIBRILLATOR TYPE PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL PAK SPINAL FUSION STIMULATOR LOE EBI, LP UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death