BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL II

    MDR report key: 233766 · Received July 27, 1999

    Report

    Report Number
    2182207-1999-00151
    Event Type
    Injury
    Date Received
    July 27, 1999
    Date of Event
    February 6, 1999
    Report Date
    June 2, 1999
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    GZB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT HAD AN ITREL II MODEL 7424 NEUROSTIMULATOR IMPLANTED ON 08/13/1992 FOR SPINAL CORD STIMULATION TO TREAT BACK PAIN. THE DEVICE MFR WAS NOTIFIED BY THE MFR ON 06/02/1999 OF A SECURITY SYSTEM THAT AN ADVERSE DEVICE INTERACTION HAD OCCURRED WITH A 3M MODEL 3802 LIBRARY DETECTION SYSTEM. THE PATIENT EXPERIENCED A SURGE FROM HIS 7424 SPINAL CORD STIMULATOR WHEN HE UNKNOWINGLY WALKED THROUGH THE LIBRARY SECURITY SYSTEM. ON JUNE 10,1999 THE HCP CALLED TO RELATE THE SAME EVENT, BUT STATED THE PATIENT HAD BEEN THROWN ACROSS THE ROOM WHEN HE ENCOUNTRED THIS LIBRARY SECURITY SYSTEM UNKNOWINGLY. THE PATIENT HAD A RECENT HERNIA REPAIR AND THEREFORE HAD A RISK OF DAMAGE TO THIS INCISION AND REPAIR WITHOUT ADEQUATE HEALING TIME. THE PATIENT HAD CALLED THE OFFICE TO HAVE THE SYSTEM CHECKED AND HAD GOOD STIMULATION WITH NO PROBLEMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL II Implant IMPLANTABLE SPINAL CORD STIMULATOR GZB MEDTRONIC, INC. 7424 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other 3586 NEUROSTIMULATION LEAD, IMPLANTED 8/13/1992 TO| PRESENT 7496-51 EXTENSION, IMPLANTED 8/13/1992 TO| PRESENT.