BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA

    MDR report key: 3636513 · Received February 20, 2014

    Report

    Report Number
    3007566237-2014-00521
    Event Type
    Injury
    Date Received
    February 20, 2014
    Date of Event
    September 20, 2013
    Report Date
    February 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 PRODUCTS: PRODUCT ID 4351, LOT # UNKNOWN, PRODUCT TYPE LEAD; 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 3116, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 4351, LOT # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    HARRISON, N.S., WILLIAMS, P.A., WALKER, M.R., NIKITINI, Y., HELLING, T.S., ABELL, T.L., LAHR, C.J. EVALUATION AND TREATMENT OF GASTRIC STIMULATOR FAILURE IN PATIENTS WITH GASTROPARESIS. SURGICAL INNOVATION. XX(X)1-6. SUMMARY: THIS STUDY EVALUATES TREATMENT OF GASTROPARESIS PATIENTS REFRACTORY TO GASTRIC ELECTRICAL STIMULATION (GES) THERAPY WITH SURGICAL REPLACEMENT OF THE ENTIRE GES SYSTEM. SOME PATIENTS WHO HAVE SYMPTOMATIC IMPROVEMENT WITH GES LATER DEVELOP RECURRENT SYMPTOMS. SOME PATIENTS IMPROVE BY SIMPLY ALTERING PULSE PARAMETER SETTINGS. OTHERS CONTINUE TO HAVE SYMPTOMS WITH MAXIMIZED PULSE PARAMETERS. FOR THESE PATIENTS, WE HAVE SHOWN THAT SURGICAL IMPLANTATION OF A NEW DEVICE AND LEADS AT A DIFFERENT GASTRIC LOCATION WILL IMPROVE SYMPTOMS OF GASTROPARESIS. THIS STUDY EVALUATES 15 PATIENTS WITH RECURRENT SYMPTOMS AFTER INITIAL GES THERAPY WHO SUBSEQUENTLY RECEIVED A SECOND GES SYSTEM. POSITIVE RESPONSE TO GES REPLACEMENT THERAPY IS EVALUATED BY SYMPTOMS SCORES FOR VOMITING, NAUSEA, EPIGASTRIC PAIN, EARLY SATIETY, AND BLOATING USING A MODIFIED LIKERT SCORE SYSTEM, 0 TO 4. TOTAL SYMPTOM SCORES IMPROVED FOR 12 OF 15 PATIENTS WITH GES REPLACEMENT SURGERY. TOTAL SCORE FOR THE REPLACEMENT GROUP DECREASED FROM 17.3 ± 1.6 TO 13.6 ± 3.7 WITH A DIFFERENCE OF 3.6 (P VALUE = .017). THIS SCORE IS COMPARED WITH THAT OF THE CONTROL GROUP WITH A PREOPERATIVE SYMPTOM SCORE OF 15.8 ± 3.6 AND POSTOPERATIVE SCORE OF 12.3 ± 3.5 WITH A DIFFERENCE OF 3.5 (P VALUE = .011). THE CONTROL GROUP SHOWED A 20.3% DECREASE IN MEAN TOTAL SYMPTOMS SCORE, WHEREAS THE STUDY GROUP SHOWED A 22.5% DECREASE IN MEAN WITH AN ABSOLUTE REDUCTION OF 2.2. REIMPLANTATION OF A GES AT A NEW GASTRIC LOCATION SHOULD BE CONSIDERED A VIABLE OPTION FOR PATIENTS WHO HAVE INITIALLY FAILED GES THERAPY FOR GASTROPARESIS. REPORTED EVENT: 15 PATIENTS HAD RECURRENT SYMPTOMS AFTER INITIAL GASTRIC ELECTRICAL STIMULATION (GES) THERAPY AND SUBSEQUENTLY RECEIVED A SECOND GES SYSTEM. IT WAS NOTED THAT THE PATIENTS HAD INITIALLY HAD SYMPTOMATIC IMPROVEMENT WITH GES AND LATER DEVELOPED RECURRENT SYMPTOMS AT AN AVERAGE OF 48 MONTHS AFTER INITIAL GES PLACEMENT. THE REPORTER STATED THAT THE INITIAL IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS WERE LEFT IN PLACE TO AVOID CONTAMINATION AND DAMAGE TO UNDERLYING MUSCLE. A NEW INS POCKET WAS THEN MADE FOR INSERTION OF A NEW INS AND NEW GASTRIC ELECTRODES WERE INSERTED IN A DIFFERENT LOCATION OF THE SEROMUSCULAR LAYER ON THE ANTERIOR SURFACE BETWEEN THE MIDDLE AND MEDIAL THIRD OF THE STOMACH. THE REPORTER STATED THAT SCARRING OF THE GASTRIC WALL AROUND THE ELECTRODES WAS CORRELATED WITH DECREASED RELIEF WITH GES THERAPY IN THE PATIENTS. 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
    107815 ENTERRA INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION 3116 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention