BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEU_ENTERRA_INS

    MDR report key: 6307336 · Received February 7, 2017

    Report

    Report Number
    3007566237-2017-00590
    Event Type
    Injury
    Date Received
    February 7, 2017
    Date of Event
    November 28, 2016
    Report Date
    February 7, 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

    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. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_ENTERRA_INS LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_ENTERRA_INS LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    DAVIS, B. R., SAROSIEK, I., BASHASHATI, M., ALVARADO, B., MCCALLUM, R. W. THE LONG-TERM EFFICACY AND SAFETY OF PYLOROPLASTY COMBINED WITH GASTRIC ELECTRICAL STIMULATION THERAPY IN GASTROPARESIS. JOURNAL OF GASTROINTESTINAL SURGERY: OFFICIAL JOURNAL OF THE SOCIETY FOR SURGERY OF THE ALIMENTARY TRACT. 2016. DOI 10.1007/S11605-016-3327-4 SUMMARY: GASTROPARESIS IS DELAYED GASTRIC EMPTYING WITHOUT MECHANICAL OBSTRUCTION. SYMPTOMATIC IMPROVEMENT CAN BE 50¿60% WITH GASTRIC ELECTRICAL STIMULATION. TO ADDRESS DELAYED GASTRIC EMPTYING, PYLOROPLASTY WAS ADDED. THIS STUDY EXAMINES THE LONG-TERM EFFICACY AND SAFETY OF SIMULTANEOUS GASTRIC ELECTRICAL STIMULATOR IMPLANTATION AND PYLOROPLASTY. IN THIS PROSPECTIVE SINGLE-ARM TRIAL CONDUCTED FROM 2012 TO 2015, 27 [23 FEMALES; MEAN AGE 43 (22¿63)] GASTROPARESIS PATIENTS WHO UNDERWENT SIMULTANEOUS GASTRIC ELECTRICAL STIMULATOR IMPLANTATION WITH HEINEKE-MIKULICZ PYLOROPLASTY WERE STUDIED. SIX (25%) UNDERWENT SIMULTANEOUS ROBOT-ASSISTED PYLOROPLASTY AND GASTRIC ELECTRICAL STIMULATOR IMPLANTATION. DIAGNOSIS OF GASTROPARESIS WAS BASED ON THE 4-H GASTRIC EMPTYING TEST DEFINED AS >60% RETENTION OF ISOTOPE AT 2 H AND >10% AT 4 H. TOTAL SYMPTOM SCORES ASSESSING SEVERITY OF NAUSEA, EARLY SATIETY, BLOATING, VOMITING, POST-PRANDIAL FULLNESS, AND EPIGASTRIC PAIN WERE OBTAINED AT BASELINE AND AT FOLLOW-UP VISITS, RANGING FROM 3 TO 38 MONTHS (MEAN: 17). FOLLOW-UP DATA FROM 24 PATIENTS WERE AVAILABLE FOR ANALYSIS. THERE WAS 71% IMPROVEMENT IN TOTAL SYMPTOM SCORE ON FOLLOW-UP. MEAN RETENTION DECREASED BY 29.6 AND 48.7% AT 2 AND 4 H AND GASTRIC EMPTYING WAS NORMALIZED IN 60%. THERE WERE NO POST-SURGICAL COMPLICATIO NS. COMBINATION OF GASTRIC ELECTRICAL STIMULATOR AND PYLOROPLASTY SIGNIFICANTLY ACCELERATED GASTRIC EMPTYING AND IMPROVED GASTROPARESIS SYMPTOMS. COMBINING THESE TWO SURGICAL THERAPIES IMPROVES BOTH SUBJECTIVE AND OBJECTIVE ENDPOINTS IN DRUG REFRACTORY GASTROPARES IS. REPORTED EVENTS: 1. 2 PATIENTS IMPLANTED FOR GASTROPARESIS HAD PSYCHIATRIC DISORDERS THAT PROMOTED SELF-CONTAMINATION OF THE WOUNDS EXPERIENCED MORBIDITY INCLUDED STIMULATOR POCKET (PULSE GENERATOR POCKET) INFECTION (6%) REQUIRED REMOVAL OF THE PULSE GENERATOR. 2. ONE PATIENT IMPLANTED FOR GASTROPARESIS WAS PRESENTED FOR CONVERSION TO SUBTOTAL GASTRECTOMY FOLLOWING AN UNSUCCESSFUL GASTRIC ELECTRIC STIMULATOR (GES) THERAPY. NO SPECIFIC DEVICE INFORMATION WAS PEROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90545 NEU_ENTERRA_INS INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R