BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2983295 · Received February 28, 2013

    Report

    Report Number
    3007566237-2013-00626
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    October 13, 2012
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4351, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD: PRODUCT ID 4351, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    TEICH, S., MOUSA. H., M., PUNATI, J., DI LORENZO, C. EFFICACY OF PERMANENT GASTRIC ELECTRICAL STIMULATION FOR THE TREATMENT OF GASTROPARESIS AND FUNCTIONAL DYSPEPSIA IN CHILDREN AND ADOLESCENTS. JOURNAL OF PEDIATRIC SURGERY. 2013;48(1):178-183. DOI: 10.1016/J.JPEDSURG.2012.10.038. SUMMARY: PERMANENT GASTRIC ELECTRICAL STIMULATION (GES) HAS BEEN PERFORMED IN ADULTS AS A TREATMENT FOR GASTROPARESIS AND REFRACTORY NAUSEA AND VOMITING IN PATIENTS WHO HAVE FAILED MEDICAL THERAPY. WE ASSESSED THE FEASIBILITY AND CLINICAL OUTCOMES OF PERMANENT GES IN CHILDREN. PERMANENT GES WAS PERFORMED IN 16 CHILDREN (10 FEMALES/6 MALES), MEDIAN AGE (B)(6). ALL PATIENTS HAD CHRONIC NAUSEA AND VOMITING REFRACTORY TO MEDICAL THERAPY AND MET ROME III CRITERIA FOR FUNCTIONAL DYSPEPSIA. SYMPTOMS, ROUTE FOR NUTRITION, AND SATISFACTION WITH PROCEDURE WERE RECORDED BEFORE AND AFTER PERMANENT GES. STATISTICAL ANALYSIS WAS PERFORMED USING PAIRED STUDENT'S T TEST. AFTER PERMANENT GES, THERE WAS SIGNIFICANT IMPROVEMENT IN SEVERITY OF VOMITING (P=0.0001), FREQUENCY OF VOMITING (P=0.0003), FREQUENCY OF NAUSEA (PB0.0001), AND SEVERITY OF NAUSEA (PB0.0001). AT THE TIME OF FOLLOW-UP,13/16 WERE ON ORAL FEEDS EXCLUSIVELY, TWO PATIENTS ON ORAL PLUS G-TUBE FEEDINGS, AND ONE PATIENT ON ORAL PLUS G-TUBE PLUS INTERMITTENT TPN. PERMANENT GES IMPROVED HEALTH IN CHILDREN WITH FUNCTIONAL DYSPEPSIA AND GASTROPARESIS WHO FAIL MEDICAL THERAPY. NO SERIOUS ADVERSE EFFECTS OF PERMANENT GES WERE NOTED. LONG-TERM EFFICACY AND SAFETY OF GES THERAPY IN CHILDREN NEED TO BE ESTABLISHED. REPORTED EVENTS: 1 PATIENT HAD SUPERFICIAL INCISIONAL ERYTHEMA THAT RESOLVED WITH ORAL ANTIBIOTICS. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88284 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00015 YR Required Intervention