BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTERRA NEUROSTIMULATOR, UNKNOWN

    MDR report key: 4554608 · Received February 27, 2015

    Report

    Report Number
    3007566237-2015-00479
    Event Type
    Injury
    Date Received
    February 27, 2015
    Date of Event
    January 17, 2015
    Report Date
    February 3, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LNQ
    PMA / PMN Number
    H990014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED 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_ENTERRA_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    SUN, Z., RODRIGUEZ, J., MCMICHAEL, J., CHAND, B., NASH, D., BRETHAUER, S., SCHAUER, P., EL-HAYEK, K., KROH, M. SURGICAL TREATMENT OF MEDICALLY REFRACTORY GASTROPARESIS IN THE MORBIDLY OBESE. SURGICAL ENDOSCOPY. 2015. DOI: 10.1007/S00464-014-3990-Z. SUMMARY: SURGICAL MANAGEMENT OF MEDICALLY REFRACTORY GASTROPARESIS REMAINS A CHALLENGE. CASE SERIES AND SMALL RETROSPECTIVE STUDIES DESCRIBE CLINICAL BENEFITS FROM SURGICAL INTERVENTION; HOWEVER, NO STUDY REPORTS THE EFFICACY OF GASTRIC ELECTRICAL STIMULATION (GES) OR ROUX-EN-Y GASTROJEJUNOSTOMY WITH OR WITHOUT NEAR-TOTAL GASTRECTOMY (RYGJ) IN MORBIDLY OBESE PATIENTS WITH SEVERE GASTROPARESIS. A CHART REVIEW WAS PERFORMED ON ALL MORBIDLY OBESE PATIENTS (BMI[35 KG/M2) WHO UNDERWENT GES OR RYGJ FOR MEDICALLY REFRACTORY GASTROPARESIS FROM MARCH 2002 TO DECEMBER 2012 AT THE CLEVELAND CLINIC. THE MAIN OUTCOMES EXAMINED WERE SYMPTOM IMPROVEMENT, POSTOPERATIVE COMPLICATIONS, AND CHANGE IN BMI. A TOTAL OF 20 MORBIDLY OBESE PATIENTS UNDERWENT GES PLACEMENT. SEVEN MORBIDLY OBESE PATIENTS HAD RYGJ WITH OR WITHOUT RESECTION OF THE REMNANT STOMACH SURGERY. ALL OPERATIONS WERE COMPLETED LAPAROSCOPICALLY. IN GES GROUP, 18 PATIENTS HAD INITIAL SYMPTOM IMPROVEMENT (90 %) AND 11 (55 %) RATED THEIR SYMPTOM IMPROVED AT THE LAST FOLLOW-UP. DURING THE AVERAGE 23 MONTHS¿ FOLLOW-UP, 9 PATIENTS (45 %) EXPERIENCED AT LEAST ONE READMISSION FOR GASTROINTESTINAL REASONS. EARLY COMPLICATIONS INCLUDED TWO INFECTIONS AT A SIMULTANEOUSLY PLACED J-TUBE SITE AND ONE SEROMA. IN THE RYGJ GROUP, ALL PATIENTS, INCLUDING 4 PATIENTS WHO FAILED GES AND SUBSEQUENTLY CONVERTED TO RYGJ, EXPERIENCED SHORT-TERM SYMPTOM IMPROVEMENT AND 5 PATIENTS (71 %) RATED THEIR SYMPTOMS AS IMPROVED AT LAST FOLLOW-UP. ONE DUODENAL STUMP LEAK HAPPENED IN THE RYGJ GROUP. THERE WERE NO 30-DAY MORTALITIES IN EITHER GROUP. THE BMI CHANGE AFTER GES IMPLANTATION WAS 0.6 ± 4 KG/M2 VERSUS -7.7 ± 4 KG/M2 AFTER RYGJ (P\0.01). GES IMPLANTATION AND RYGJ ARE BOTH EFFECTIVE IN TERMS OF SYMPTOM CONTROL FOR MEDICALLY REFRACTORY GASTROPARESIS IN MORBIDLY OBESE. BOTH OPTIONS CAN BE PERFORMED IN A MINIMALLY INVASIVE FASHION WITH LOW MORBIDITY. PATIENTS WHO HAVE NO IMPROVEMENT OF SYMPTOMS FOR REFRACTORY GASTROPARESIS AFTER GES IMPLANTATION CAN BE SUCCESSFULLY CONVERTED LAPAROSCOPICALLY TO RYGJ. REPORTED EVENTS: 1. 2 MORBIDLY OBESE PATIENTS WITH GASTRIC ELECTRICAL STIMULATION (GES) FOR TREATMENT OF GASTROPARESIS EXPERIENCED INFECTIONS AT A SIMULTANEOUSLY PLACED J-TUBE SITE AFTER SURGERY. 2. 9 MORBIDLY OBESE PATIENTS WITH GASTRIC ELECTRICAL STIMULATION (GES) FOR TREATMENT OF GASTROPARESIS EXPERIENCED AT LEAST ONE READMISSION FOR GASTROINTESTINAL REASONS DURING THE AVERAGE 23 MONTHS OF FOLLOW-UP. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    138086 ENTERRA NEUROSTIMULATOR, UNKNOWN INTESTINAL STIMULATOR LNQ MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00043 YR Hospitalization| R