BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_ENTERRA_INS

    MDR report key: 7690154 · Received July 16, 2018

    Report

    Report Number
    3007566237-2018-02096
    Event Type
    Injury
    Date Received
    July 16, 2018
    Date of Event
    December 13, 2017
    Report Date
    July 16, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_ENTERRA_INS, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    KOUL, A., DACHA, S., MEKAROONKAMOL, P., LI., X., LI, L., SHAHNAVAZ, N., KEILIN, S., WILLINGHAM, F. F., CHRISTIE, J., CAI, Q. FLUOROSCOPIC GASTRIC PERORAL ENDOSCOPIC PYLOROMYOTOMY (G-POEM) IN PATIENTS WITH A FAILED GASTRIC ELECTRICAL STIMULATOR. GASTROENTEROL REP (OXF). 2018. 6(2): 122-126. DOI: 10.1093/GASTRO/GOX040 SUMMARY: GASTRIC ELECTRICAL STIMULATORS (GESS) HAVE BEEN USED TO TREAT REFRACTORY GASTROPARESIS IN PATIENTS WHO FAIL INITIAL THERAPIES SUCH AS DIETARY MODIFICATIONS, CONTROL OF PSYCHOLOGICAL STRESSORS AND PHARMACOLOGIC TREATMENT. MORE RECENTLY, GASTRIC PERORAL ENDOSCOPIC PYLOROMYOTOMY (G-POEM) HAS EMERGED AS A NOVEL ENDOSCOPIC TECHNIQUE TO TREAT REFRACTORY GASTROPARESIS. WE PRESENT A CASE SERIES OF PATIENTS WITH REFRACTORY GASTROPARESIS WHO FAILED TREATMENT WITH AN IMPLANTED GES THAT WERE SAFELY TREATED WITH G-POEM PERFORMED UNDER FLUOROSCOPY AS A SALVAGE THERAPY. CASES OF G-POEM PERFORMED ON PATIENTS WITH REFRACTORY GASTROPARESIS WHO FAILED TREATMENT WITH A GES WERE RETROSPECTIVELY REVIEWED. ALL G-POEM PROCEDURES WERE PERFORMED UNDER FLUOROSCOPIC GUIDANCE WITH THE GES STILL IN PLACE. GASTROPARESIS CARDINAL SYMPTOMS INDEX (GCSI) AND GASTRIC EMPTYING SCINTIGRAPHY WERE ASSESSED BEFORE AND AFTER THE PROCEDURE. PATIENTS WERE FOLLOWED UP FOR UP TO 18 MONTHS POST PROCEDURE. FIVE PATIENTS UNDERWENT G-POEM AFTER FAILING TREATMENT WITH A GES. UNDER FLUOROSCOPY, THE GES AND THEIR LEADS WERE VISUALIZED IN DIFFERENT PARTS OF THE STOMACH. ONE GES LEAD WAS OBSERVED AT THE ANTRUM NEAR THE MYOTOMY SITE. ALL PROCEDURES WERE SUCCESSFULLY COMPLETED WITHOUT COMPLICATIONS. PATIENTS¿ GCSI DECREASED BY AN AVERAGE OF 62% 1 MONTH POST PROCEDURE. PATIENTS ALSO HAD NOTABLE IMPROVEMENTS IN GASTRIC EMPTYING 2 MONTHS POST PROCEDURE. IN PATIENTS WITH REFRACTORY GASTROPARESIS WHO HAVE FAILED TREATMENT WITH A GES, G-POEM CAN BE SAFE AND EFFECTIVE WITHOUT REMOVING THE GES. TO VISUALIZE THE GES AND AVOID CUTTING GES LEADS DURING MYOTOMY, THE PROCEDURE SHOULD BE PERFORMED UNDER FLUOROSCOPY. REPORTED EVENTS: ONE PATIENT SUBSEQUENTLY UNDERWENT REMOVAL OF THE GASTRIC STIMULATOR 6 MONTHS POST PROCEDURE AND CONTINUES TO DO WELL. FIVE (5) PATIENTS IN THE YEAR PRIOR TO UNDERGOING G-POEM ON AVERAGE EXPERIENCED 3.3 HOSPITALIZATIONS AS WELL AS 3.75 ADDITIONAL EMERGENCY ROOM (ER) VISITS FOR GASTROPARESIS-RELATED ISSUES. NO SPECIFIC DEVICE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    532784 NEU_ENTERRA_INS INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R