BEUDAMED
    FDA Adverse Event Other Summary report: N

    ITREL

    MDR report key: 323524 · Received March 28, 2001

    Report

    Report Number
    6000032-2001-00099
    Event Type
    Other
    Date Received
    March 28, 2001
    Report Date
    March 23, 2001
    Manufacturer
    MEDTRONIC INC.
    Product Code
    GZB
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT UNDERWENT IMPLANTATION OF AN ITREL NEUROSTIMULATION SYSTEM IN 04/1995 FOR RELIEF OF PAIN DUE TO FAILED BACK SURGERY SYNDROME. THE PT UNDERWENT REPLACEMENT OF IPG IN 2000. THE PT'S ATTORNEY CONTACTED THE MFR ALLEGING "PLAINTIFF WAS CONTINUING TO SUFFER FROM PAIN RESULTING FROM CHRONIC BACK FAILURE AND THAT 6 DAYS LATER, DR. RECOGNIZED THAT THERE WAS A NEED TO REPLACE THE WIRE FROM THE EPIDURAL ELECTRODE TO THE PULSE GENERATOR".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13748 ITREL IMPLANTABLE PULSE GENERATOR GZB MEDTRONIC INC. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other UNK NEUROSTIMULATION LEAD, IMPLANTED 4/1995.