BEUDAMED
    FDA Adverse Event Other Summary report: N

    ITREL 3

    MDR report key: 140183 · Received December 26, 1997

    Report

    Report Number
    6000032-1997-00323
    Event Type
    Other
    Date Received
    December 26, 1997
    Date of Event
    January 1, 1997
    Report Date
    December 4, 1997
    Manufacturer
    MEDTRONIC INC.
    Product Code
    GZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    REPORT FORM PT SERVICES DEPARTMENT THAT PT WAS HAVING "BURNING PAIN AND JOTTING SENSATIONS IN SPINE. "PT WAS ASKED TO FOLLOW UP WITH PHYSICIAN AS TO REPROGRAMMING DEVICE. NO FURTHER INFO ON THE PT OR DEVICE IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 Implant IMPLANTABLE PULSE GENERATOR GZB MEDTRONIC INC. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other 2. MODEL 7495-51 EXTENSION| 1. MODEL 3487A LEAD, LOT#L31773