BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPINAL PAK STIMULATOR

    MDR report key: 539922 · Received August 18, 2004

    Report

    Report Number
    2242816-2004-00011
    Event Type
    Death
    Date Received
    August 18, 2004
    Date of Event
    February 20, 2002
    Report Date
    August 13, 2004
    Manufacturer
    EBI, L.P.
    Product Code
    GZI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT SPINAL FUSION SURGERY IN 03/01. SPINAL PAK STIMULATOR PRESCRIBED ON 4/01. PT SUBSEQUENTLY DEVELOPED CANCER AND DIED IN 2002.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINAL PAK STIMULATOR EXTERNAL STIMULATOR GZI EBI, L.P. UNK *

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death