BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 8419287 · Received March 14, 2019

    Report

    Report Number
    3007566237-2019-00613
    Event Type
    Injury
    Date Received
    March 14, 2019
    Date of Event
    July 30, 2018
    Report Date
    March 13, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SHADA A, NIELSEN A, MAROWSKI S, HELM M, FUNK LM, KASTENMEIER A, LIDOR A, GOULD JC. WISCONSIN'S ENTERRA THERAPY EXPERIENCE: A MULTI-INSTITUTIONAL REVIEW OF GASTRIC ELECTRICAL STIMULATION FOR MEDICALLY REFRACTORY GASTROPARESIS. SURGERY. 2018;16 4(4):760-765. DOI: 10.1016/J.SURG.2018.04.043 A2: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S ONLINE PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: ASKU, UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE SUMMARY: THE AUTHORS SOUGHT TO EVALUATE THE OUTCOMES OF GASTRIC ELECTRICAL STIMULATION (GES) IN THE STATE OF WISCONSIN DURING A MORE THAN 10-YEAR PERIOD. A TOTAL OF 119 PATIENTS RECEIVED GASTRIC ELECTRICAL STIMULATION THERAPY (64 DIABETIC AND 55 IDIOPATHIC). THE AUTHORS ULTIMATELY CONCLUDED THAT GES THERAPY LED TO THE IMPROVEMENT OF SYMPTOMS OF GASTROPARESIS AND A BETTER QUALITY OF LIFE. PATIENTS WERE ABLE TO DECREASE THE USE OF PROKINETIC AND NARCOTIC MEDICATIONS AND ACHIEVE LONG-TERM SATISFACTION. REPORTED EVENTS: 1. 4 PATIENTS HAD A NEW FEEDING JEJUNOSTOMY TUBE PLACED AFTER THE INITIATION OF GASTRIC ELECTRICAL STIMULATION (GES). IT WAS NOTED THE ADDITIONAL PROCEDURES WERE GASTROPARESIS RELATED. 2. 2 PATIENTS UNDERWENT A PYLOROPLASTY AFTER THE INITIATION OF GES. IT WAS NOTED THE ADDITIONAL PROCEDURES WERE GASTROPARESIS RELATED. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214347 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention