BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ITREL 3

    MDR report key: 1181000 · Received September 29, 2008

    Report

    Report Number
    3004209178-2008-06203
    Event Type
    Malfunction
    Date Received
    September 29, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: LEAD OR EXTENSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCES ON ELECTRODES 3 AND 4 WERE GREATER THAN 4000 OHMS AND NOT USED IN PROGRAMMING. IMPEDANCES ON ELECTRODES 1 AND 2 WERE FINE. THE PT HAD GOOD THERAPEUTIC EFFECT. THE IMPLANTABLE NEUROSTIMULATOR REACHED END OF SERVICE AND NEEDED TO BE REPLACED. POST SURGICALLY IMPEDANCES ON ELECTRODES 3 AND 4 REMAINED HIGH. IT WAS REPORTED THAT THE PT HAD GOOD THERAPEUTIC EFFECT AFTER SURGERY WITH THE NEW IMPLANTABLE NEUROSTIMULATOR. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO 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 57 YR LEAD: MODEL 3586| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7496| EXPLANTED:| IMPLANTED: