BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENTERRA

    MDR report key: 1233824 · Received November 17, 2008

    Report

    Report Number
    2182207-2008-07560
    Event Type
    Death
    Date Received
    November 17, 2008
    Report Date
    October 31, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    HDE99015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    JOURNAL REFERENCE: MCKENNA D, BEVERSTEIN G, REICHELDERFER M, GAUMNITZ E, GOULD J. GASTRIC ELECTRICAL STIMULATION IS AN EFFECTIVE AND SAFE TREATMENT FOR MEDICALLY REFRACTORY GASTROPARESIS. SURGERY. 2008; 144(4):566-574. GASTROPARESIS IS CHARACTERIZED BY DELAYED GASTRIC EMPTYING IN THE ABSENCE OF OBSTRUCTION. COMMON SYMPTOMS INCLUDE NAUSEA, VOMITING, AND ABDOMINAL PAIN. SEVERE GASTROPARESIS CAN RESULT IN RECURRENT HOSPITALIZATIONS, MALNUTRITION, AND EVEN DEATH. GASTRIC ELECTRICAL STIMULATION (GES) IS A LOW MORBIDITY TREATMENT THAT MAY BE EFFECTIVE IN PATIENTS WHO ARE REFRACTORY TO MEDICAL THERAPY. NINETEEN PATIENTS WERE FOLLOWED FOR MORE THAN 35 MONTHS. REPORTABLE EVENT: ONE PATIENT WITH A HISTORY OF TYPE 1 DIABETES MELLITUS AND DG DIED 4 MONTHS POSTOPERATIVELY FROM WHAT WAS PRESUMED TO BE A CARDIAC EVENT. NO AUTOPSY WAS PERFORMED. EXACT CAUSE UNKNOWN. SEE MFG REPORT # 2182207200807558.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENTERRA LNQ MEDTRONIC NEUROMODULATION 3116 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death LEAD: MODEL UNK N=2