BEUDAMED
    FDA Adverse Event Death Summary report: N

    MEDTRONIC

    MDR report key: 852956 · Received May 9, 2007

    Report

    Report Number
    MW1042846
    Event Type
    Death
    Date Received
    May 9, 2007
    Date of Event
    April 25, 2007
    Report Date
    May 9, 2007
    Manufacturer
    MEDTRONIC NEUROLOGICAL
    Product Code
    GZB
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD RE-IMPLANTATION OF SPINAL CORD STIMULATOR S/P REMOVAL OF INFECTED SPINAL CORD STIMULATOR. PATIENT HAD PROCEDURE WITHOUT COMPLICATIONS. AT END OF PROCEDURE PATIENT BECAME HYPOTENSIVE AND BREATHING CHANGES. EFFORTS TO RESUSCITATE FAILED. PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC SPINAL CORD STIMULATOR GZB MEDTRONIC NEUROLOGICAL * 37713
    2 MEDTRONIC LEAD KIT GZB MEDTRONIC NEUROLOGICAL * *
    3 MEDTRONIC ACCESSORY KIT GZB MEDTRONIC NEUROLOGICAL * *
    4 RESTORE * GZB MEDTRONIC NEUROLOGICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death