BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1213782 · Received October 28, 2008

    Report

    Report Number
    3004209178-2008-06951
    Event Type
    Injury
    Date Received
    October 28, 2008
    Date of Event
    September 1, 2008
    Report Date
    September 30, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THERAPY IMPEDANCE MEASUREMENTS OF THE SYSTEM WERE >4000 OHMS. IMPEDANCES WERE CONDUCTED AT 8-9 VOLTS. THE PATIENT FELT NO STIMULATION ON ELECTRODE 1 AND 3. ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT UNDERWENT REPLACEMENT OF THE LEAD IN 2008. THE PATIENT WAS DOING MUCH BETTER. THE PATIENT FELT STIMULATION AT 3 VOLTS AND IMPEDANCES WERE NORMAL.

    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 Required Intervention LEAD: MODEL 3487A| PROGRAMMER: MODEL 7434A| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489