BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1083382 · Received July 28, 2008

    Report

    Report Number
    3004209178-2008-04460
    Event Type
    Malfunction
    Date Received
    July 28, 2008
    Report Date
    June 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A PREVIOUS ISSUE WITH A LEAD MIGRATION. NO SYMPTOMS OR OUTCOME WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 IMPLANTED| LEAD MODEL 3487A-33 LOT# V003444| EXPLANTED| PROGRAMMER MODEL 7434A LOT# NGL026171P| EXTENSION MODEL 7489 LOT# NHU094317V| EXPLANTED| EXPLANTED| IMPLANTED| IMPLANTED