BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ITREL 3

    MDR report key: 1120761 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04996
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    July 18, 2008
    Report Date
    July 18, 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
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    THE PT WAS GETTING SUCCESSFUL CHEST PAIN AND ANGINA RELIEF, HAD A LOSS OF THERAPEUTIC EFFECT, AND STARTED EXPERIENCING BELLY AND LEG STIMULATION. REPROGRAMMING OF THE DEVICE DID NOT PROD ADEQUATE STIMULATION FOR THE PT. AN X-RAY WAS TAKEN (DATE AND RESULTS NOT REPORTED). THE HCP SUSPECTED LEAD MIGRATION. PREOPERATIVELY ALL IMPEDANCE CONFIGURATIONS WERE WITHIN NORMAL LIMITS. THE LEAD WAS REPLACED. INTRAOPERATIVELY, THE PT EXPERIENCED GOOD STIMULATION IN THE DESIRED AREA USING THE SCREENING CABLES. WHEN THE LEAD WAS CONNECTED TO THE EXISTING EXTENSION AND NEUROSTIMULATOR THE PT AGAIN EXPERIENCED BELLY AND LEG STIMULATION. THE PT WASN'T EXPERIENCING OTHER ADVERSE STIMULATION. IMPEDANCES WERE SIMILAR TO THOSE FOUND PRE-SURGERY. THE HCP THEN EXPLANTED THE EXTENSION AND NEUROSTIMULATOR. THE PT EXPERIENCED ADEQUATE STIMULATION WHILE TRAILING THE NEW LEAD. A NEW EXTENSION AND STIMULATOR WERE IMPLANTED APPROX A WEEK LATER.

    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 EXTENSION MODEL 7489 LOT # NHU099218V IMPLANTED| EXPLANTED| EXPLANTED| LEAD MODEL 3887 LOT # J0537488V IMPLANTED| PROGRAMMER MODEL 7434 LOT # NGL025459P