BEUDAMED
    FDA Adverse Event Death Summary report: N

    ITREL 3

    MDR report key: 1082235 · Received July 25, 2008

    Report

    Report Number
    2950887-2008-04371
    Event Type
    Death
    Date Received
    July 25, 2008
    Report Date
    March 28, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    LITERATURE ARTICLE: AL-JUBURI, ET AL. "LAPAROSCOPY SHORTENS LENGTH OF STAY IN PTS WITH GASTRIC ELECTRICAL STIMULATORS". JSLS JOURNAL OF THE SOCIETY OF LAPAROENDOSCOPIC SURGEONS. 2005; 9:305-310. EIGHTEEN PTS WITH GASTROPARESIS, CAUSES OF DIABETES MELLITUS, POSTSURGICAL AND IDIOPATHIC DISEASE, UNDERWENT LAPAROSCOPIC PLACEMENT OF A SYSTEM FOR GASTRIC ELECTRICAL STIMULATION WERE COMPARED RETROSPECTIVELY WITH EIGHTEEN PTS WHO UNDERGOING LAPAROTOMY FOR IDENTICAL GES DEVICES FOR THE SAME PRIMARY DIAGNOSIS. PTS WERE FOLLOWED FOR A MEAN OF 28.8 MONTHS IN THE LAPAROSCOPIC GROUP AND PTS WERE FOLLOWED 42.7 MONTHS IN THE LAPAROTOMY GROUP. OVER THE REPORTED PERIOD ONE PT DIED SECONDARY TO PULMONARY EMBOLUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ITREL 3 LNQ MEDTRONIC NEUROMODULATION 7425 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death EXPLANTED| IMPLANTED| GASTRIC LEAD MODEL UNK LOT #UNK| IMPLANTED| EXPLANTED| GASTRIC LEAD MODEL UNK LOT # UNK