BEUDAMED
    FDA Adverse Event Other Summary report: N

    ITREL

    MDR report key: 501558 · Received December 11, 2003

    Report

    Report Number
    2182207-2003-01157
    Event Type
    Other
    Date Received
    December 11, 2003
    Report Date
    November 19, 2003
    Manufacturer
    NEURO
    Product Code
    LHG
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    MANUFACTURER REPRESENTATIVE REPORTED INCORRECT LEAD WAS REPLACED. ADDITIONAL SURGERY WAS PERFORMED TO REPLACE THE CORRECT LEAD. MANUFACTURER REP REPORTS PT IS DOING FINE AFTER SECOND SURGERY. THE DEVICE WAS EXPLANTED BUT NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL LEAD LHG NEURO 3986ILC N25820

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization IPG MODEL 7427 LOT# NFE123179H IMPL: 2002,| EXP: UNK.| EXT MODEL 7495 IMPLANT: 2002,| EXP: UNK.