BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_ENTERRA_INS

    MDR report key: 6959214 · Received October 18, 2017

    Report

    Report Number
    3007566237-2017-04443
    Event Type
    Injury
    Date Received
    October 18, 2017
    Date of Event
    July 15, 2017
    Report Date
    October 18, 2017
    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

    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. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_ENTERRA_INS, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MOWZOON, M., MACEDO, F. I. B., KAUR, J., KOLACHALAM, R. EFFECTIVENESS AND FEASIBILITY OF ROBOTIC GASTRIC NEUROSTIMULATOR PLACEMENT IN PATIENTS WITH REFRACTORY GASTROPARESIS. J ROBOT SURG. 2017. DOI: 10.1007/S11701-017-0732-Y SUMMARY: GASTRIC NEUROSTIMULATION (GNS) WITH ENTERRA_THERAPY DEVICE (MEDTRONIC, (B)(4)) APPEARS AS THE LAST RESORT FOR PATIENTS WITH REFRACTORY GASTROPARESIS. CURRENTLY, THE DEVICE HAS HUMANITARIAN USE STATUS BY FOOD AND DRUG ADMINISTRATION, THEREBY REQUIRING FURTHER INVESTIGATION. WE AIM TO DESCRIBE ITS FEASIBILITY AND CLINICAL OUTCOMES USING ROBOTIC TECHNIQUE. FROM JUNE 2014 TO SEPTEMBER 2016, 15 CONSECUTIVE PATIENTS UNDERWENT ROBOTIC INSERTION OF ENTERRA_ DEVICE. PATIENT DEMOGRAPHICS, COMORBIDITIES, AND CLINICAL OUTCOMES INCLUDING MORTALITY, LENGTH OF STAY, READMISSION RATES, REOPERATION AND COMPLICATIONS WERE RETROSPECTIVELY COLLECTED. PATIENTS WERE ALSO ASSESSED BASED ON A VALIDATED 14-POINT QUESTIONNAIRE REGARDING SATISFACTION WITH THE OPERATION, QUALITY OF LIFE AND SYMPTOMATIC RELIEF. MEAN AGE WAS 41.6 YEARS ± 13.8 AND THERE WERE 11 FEMALES (73.3%). NO MORTALITY WAS REPORTED. THE ANNUAL HOSPITAL ADMISSIONS WERE REDUCED AFTER GNS (2.5 ± 4.1 VS. 3.6 ± 4.4, P = 0.004). THE FREQUENCY OF BLOATING (P = 0.029) AND SEVERITY OF EMESIS (P = 0.038), EARLY SATIETY (P = 0.042) AND BLOATING (P = 0.031) WERE REDUCED AFTER GNS. THE SEVERITY AND FREQUENCY TOTAL SCORES WERE ALSO IMPROVED AFTER GNS (12.6 ± 1.4 VS. 18.1 ± 2.7, P = 0.008 AND 12.9 ± 2.2 VS. 16.1 ± 1.1, P = 0.016, RESPECTIVELY). THIS IS THE FIRST REPORT DESCRIBING THE CLINICAL EXPERIENCE WITH ROBOTIC INSERTION OF GNS DEVICE. THIS APPROACH IS SAFE AND FEASIBLE AND SEEMS TO HAVE SIMILAR LONG-TERM OUTCOMES AS LAPAROSCOPIC TECHNIQUE. POTENTIAL ADVANTAGES TO ROBOTIC TECHNIQUE INCLUDE ENHANCED DEXTERITY AND SUTURING OF THE DEVICE WITHIN GASTRIC WALL. FURTHER EXPERIENCE WITH LARGE PROSPECTIVE STUDIES AND RANDOMIZED CLINICAL TRIALS MAY BE WARRANTED. REPORTED EVENTS: FOUR (4) PATIENTS REQUIRED READMISSION WITHIN 30 DAYS AFTER THE PLACEMENT OF THE DEVICE. TWO (2) PATIENTS OPTED FOR DEVICE REMOVAL AFTER 6 MONTHS AND 1 YEAR DUE TO LACK OF SYMPTOMATIC RELIEF. THERE WAS A TRANSIENT STATISTICAL SIGNIFICANT REDUCTION IN SEVERITY AND FREQUENCY IN VOMITING, NAUSEA, EARLY SATIETY, POST PRANDIAL FULLNESS, EPIGASTRIC PAIN AND EPIGASTRIC BURNING IN THE FIRST 2 POSTOPERATIVE VISITS, HOWEVER, THE SCORE RECURRED TO BASELINE IN THE SUBSEQUENT VISITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738223 NEU_ENTERRA_INS INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R