BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3250553 · Received July 26, 2013

    Report

    Report Number
    3007566237-2013-02493
    Event Type
    Injury
    Date Received
    July 26, 2013
    Date of Event
    January 29, 2013
    Report Date
    July 8, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. CONCOMITANT PRODUCT: PRODUCT ID 3116, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3116, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3116, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3116, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3116, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_ENS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE EXTERNAL NEUROSTIMULATOR; PRODUCT ID 435135, LOT # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    LU, P.L., TEICH, S., LORENZO, C.D., SKAGGS, B., ALHAJJ, M., MOUSA, H.M. IMPROVEMENT OF QUALITY OF LIFE AND SYMPTOMS AFTER GASTRIC ELECTRICAL STIMULATION IN CHILDREN WITH FUNCTIONAL DYSPEPSIA. NEUROGASTROENTEROLOGY AND MOTILITY: THE OFFICIAL JOURNAL OF THE (B)(4) GASTROINTESTINAL MOTILITY SOCIETY. 2013;25(7):567-E456. SUMMARY: OUR OBJECTIVE IS TO EVALUATE THE EFFECT OF GASTRIC ELECTRICAL STIMULATION (GES) ON SYMPTOMS AND QUALITY OF LIFE FOR PEDIATRIC PATIENTS WITH FUNCTIONAL DYSPEPSIA (FD). TWENTY-FOUR PATIENTS (16 FEMALE, MEDIAN 15 YEARS) WERE TREATED WITH GES FOR FD AFTER A MEDIAN OF 24 MONTHS OF SYMPTOMS (3 MONTHS¿14 YEARS). AT BASELINE, 46% REQUIRED TUBE FEEDS AND 25% PARENTERAL NUTRITION. SIXTY PERCENT HAD GASTROPARESIS. THE PEDSQL GI MODULE (PEDSQL) WAS COMPLETED FOR 18/24 BOTH PRE-/POST-GES AFTER A MEDIAN OF 8 MONTHS. PATIENTS ALSO COMPLETED THE SYMPTOM MONITOR WORKSHEET (SMW)PRE-/POST-GES AFTER A MEDIAN OF 6 MONTHS. PRE-/POST-GES GLOBAL HEALTH WAS ALSO ASSESSED. SIGNIFICANT IMPROVEMENTS WERE SEEN IN MULTIPLE AREAS OF THE PEDSQL, INCLUDING STOMACH PAIN/UPSET, FOOD/DRINK LIMITS, HEARTBURN/REFLUX, GAS/BLOATING, PATIENT WORRY, MEDICATION TOLERANCE, AND CONSTIPATION (P <(><<)> 0.05). A DECREASE WAS FOUND IN COMBINED SYMPTOM SEVERITY/FREQUENCY BASED ON SMW (P <(><<)> 0.01). IMPROVEMENTS WERE MADE IN ALL CATEGORIES, INCLUDING VOMITING, NAUSEA, EARLY SATIETY, BLOATING, FULLNESS, EPIGASTRIC PAIN, AND BURNING (P <(> <<)> 0.01). IMPROVEMENTS IN PEDSQL/SMW SCORES REMAINED WHEN ANALYSIS WAS LIMITED TO NORMAL OR DELAYED GASTRIC EMPTYING (P <(><<)> 0.05, P <(><<)> 0.05). THIRTEEN PERCENT NEEDED TUBE FEEDS AND 13% PARENT ERAL NUTRITION AFTER GES. SIXTY-FIVE PERCENT REPORTED THAT THEIR HEALTH WAS MUCH IMPROVED AFTER GES VS 15% THE SAME OR WORSE. FIVE PATIENTS EXPERIENCED COMPLICATIONS, PRIMARILY MILD ABDOMINAL DISCOMFORT. IN THE LARGEST SERIES TO DATE OF PEDIATRIC PATIENTS WHO HAVE UNDERGONE GES FOR FD, WE FOUND SIGNIFICANT IMPROVEMENTS IN UPPER GASTROINTESTINAL SYMPTOMS, QUALITY OF LIFE, AND PERCEPTION OF GLOBAL HEALTH. PATIENTS WERE LESS DEPENDENT ON TUBE FEEDING OR PARENTERAL NUTRITION. REPORTED EVENT: 1 PATIENT WAS FOUND TO HAVE A FAILED BATTERY THAT REQUIRED REPLACEMENT DURING A SECOND PROCEDURE LESS THAN 1 YEAR AFTER INITIAL PLACEMENT. ONE PATIENT WITH HISTORY OF REQUIRING PARENTERAL NUTRITION AND SHORT BOWEL SYNDROME SECONDARY TO GASTROSCHISIS EXPERIENCED A SMALL BOWEL OBSTRUCTION A FEW MONTHS AFTER STIMULATION INITIATION. SHE WAS RESTARTED ON PARENTERAL NUTRITION AFTER HER BOWEL OBSTRUCTION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350184 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R