BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 2983809 · Received February 28, 2013

    Report

    Report Number
    3007566237-2013-00635
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    August 23, 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
    TX, 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. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PATIENT. THE PATIENT INFORMATION PROVIDED IN SECTION A IS AN AVERAGE FOR ALL THE PATIENTS. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SAROSIEK, I., FORSTER, J., LIN, Z., CHERRY, S., SAROSIEK, J., MCCALLUM, R. THE ADDITION OF PYLOROPLASTY AS A NEW SURGICAL APPROACH TO ENHANCE EFFECTIVENESS OF GASTRIC ELECTRICAL STIMULATION THERAPY IN PATIENTS WITH GASTROPARESIS. NEUROGASTROENTEROLOGY AND MOTILITY : THE OFFICIAL JOURNAL OF THE EUROPEAN GASTROINTESTINAL MOTILITY SOCIETY. 2013;25(2):134-E180. DOI: 10.1111/NMO.12032. SUMMARY:IMPROVEMENT OF GASTROPARESIS (GP) SYMPTOMS HAS BEEN DOCUMENTED IN PATIENTS TREATED WITH GASTRIC ELECTRICAL STIMULATION (GES), BUT ACCELERATION OF GASTRIC EMPTYING (GET) IS UNPREDICTABLE. THE AIM OF OUR STUDY WAS TO EVALUATE THE ADVANTAGE OF ADDING SURGICAL PYLOROPLASTY (PP) TO GES FOR IMPROVEMENT OF GET AND CONTROL OF SYMPTOMS IN DIABETES MELLITUS (DM), IDIOPATHIC (ID), AND POSTVAGOTOMY (P-V)GP. METHODS A TOTAL OF 49 (17 - DM, 9 - ID, 23 - P-V) CONSECUTIVE GP PATIENTS: 38 FEMALE; MEAN AGE 42 (21-73 YEARS); MEAN WEIGHT 158 LBS (102-245), UNDERWENT GES IMPLANTATION, AND 26 (53%) ADDITIONALLY RECEIVED PP. TOTAL SYMPTOMS SCORE, 4-H GET, ADVERSE EVENTS (AES), AND DAYS OF HOSPITALIZATIONS WERE CAPTURED AT BASELINE AND AT THE LAST VISIT. KEY RESULTS: THE MEAN FOLLOW-UP WAS 7 MONTHS. TOTAL SYMPTOMS SCORE IN PATIENTS WHO RECEIVED ENTERRA AND PP OR GES ALONE SIGNIFICANTLY IMPROVED COMPARED TO THEIR BASELINE SCORES (P <(><<)>0.001). GET IMPROVED BY 64% AT 4 H (P <(><<)> 0.001) IN PATIENTS WITH ENTERRA AND PP, COMPARED TO 7% OBSERVED AFTER GES THERAPY ALONE (NS). THE MOST IMPRESSIVE ACCELERATION OF GET WAS SEEN IN THE P-V GROUP, WHO RECEIVED BOTH THERAPIES (P = 0.004) AND 8 (60%) OF THEM NORMALIZED GET. NO AES ACCOMPANIED THE ADDITION OF PP TO THE ENTERRA SURGERY. CONCLUSIONS <(>&<)> INFERENCES (I) IN DRUG-REFRACTORY GP THE ADDITION OF PP TO GES SUBSTANTIALLY ACCELERATED GET; (II) THE GET RESPONSE IN P-V GROUP WAS THE MOST IMPRESS IVE; (III) SIGNIFICANT SYMPTOM REDUCTIONS WERE ACHIEVED BY BOTH PROCEDURES; AND (IV) PP ADDED TO GES MAY SUSTAIN BETTER LONG-TERM SYMPTOMS CONTROL PARTICULARLY IN THE P-V SETTING. REPORTED EVENTS: 1. 1 PATIENT WHO RECEIVED GASTRIC ELECTRICAL STIMULATION AND PYLOROPLASTY EXPERIENCED A WOUND INFECTION. 2. 1 PATIENT WHO RECEIVED ONLY GASTRIC ELECTRICAL STIMULATION EXPERIENCED A WOUND INFECTION. 3. AN UNKNOWN NUMBER OF PATIENTS WHO RECEIVED GASTRIC ELECTRICAL STIMULATION AND PYLOROPLASTY WERE HOSPITALIZED FOR AN AVERAGE OF ONE DAY. 4. AN UNKNOWN NUMBER OF PATIENTS WHO RECEIVED GASTRIC ELECTRICAL STIMULATION ONLY WERE HOSPITALIZED FOR AN AVERAGE OF SIX DAYS. 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
    87905 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R