MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_ENTERRA_INS; INTESTINAL STIMULATOR

Model Number NEU_ENTERRA_INS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Dehydration (1807); Nausea (1970); Vomiting (2144); Discomfort (2330); Complaint, Ill-Defined (2331); Obstruction/Occlusion (2422); Post Operative Wound Infection (2446)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

Please note that this date is based off of the date the article was accepted for publication as the event dates were not provided in the published literature.Other applicable components are: product id neu_enterra_ins, lot# unknown.Product type implantable neurostimulator, product id neu_enterra_ins, lot# unknown.Product type implantable neurostimulator, product id neu_enterra_ins, lot# unknown.Product type implantable neurostimulator, product id neu_enterra_ins, lot# unknown.Product type implantable neurostimulator, product id neu_enterra_ins, lot# unknown.Product type implantable neurostimulator, product id neu_enterra_ins, lot# unknown.Product type implantable neurostimulator, product id neu_enterra_ins, lot# unknown.Product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Wakamatsu, k., perez, quirante, f., montorfano, l., lo menzo e., seto, y., rosenthal, r.J.Laparoscopic treatment of gastroparesis: a single center experience.Surg obes relat dis.2017.00-00.Doi: 10.1016/j.Soard.2017.07.029 summary: gastroparesis (gp) is a chronic disorder of gastric motility with delayed gastric emptying.Gastric electrical stimulator (ges) implantation and roux-en-y gastric bypass (rygb) are surgical options for medically refractory gp.A retrospective chart review was performed of all patients who underwent surgical treatment of gp from february 2003 to december 2014.Subgroup analysis was performed based on etiology of gp (dm versus ip) and procedure received (ges versus rygb).Postoperative outcomes and postoperative symptom improvements were compared between groups.Results: of 93 patients, 47 (50.5%) had ip and 46 (49.5%) had dm.The majority underwent ges implantation (83.8%, n¼ 78), and 15 patients (16%) underwent rygb.There were significant differences in hospital stay (2 versus 3 days) and reoperation rate (30% versus 7%) between ip and dm.Operation time, complication rate, and 30-day readmission rate were similar in both groups.Dm patients significantly improved gp-related complaints compared with preoperatively.Ip patients also improved nausea and vomiting and had no change in abdominal pain between pre- and postoperative period.Ges showed significant improvement of nausea, vomiting, and abdominal pain.Rygb showed improvement of nausea, but not vomiting or abdominal pain.Conclusions: surgery is a feasible intervention for gp for both dm and ip patients; however, based on the data presented in this manuscript and the current literature, the use of gastric bypass as an effective treatment modality for patients with intractable gp remains highly controversial.Care must be taken for ip patients in the postoperative period due to high incidence of reoperation.Although both procedures offer some degree of symptomatic improvement, ges seems to provide improvement of more gp symptoms.However, there is no significant difference in the need for postoperative medications regardless of the procedure used.Reported events: 1.13 patients underwent the removal or replacement of gastric electrical stimulator (ges) due to abdominal discomfort that resolved after relocation.2.3 patients underwent the removal of the gastric electrical stimulator (ges) due to a conversion to roux-en-y gastric bypass (rygb) because of refractory symptoms of nausea and vomiting.3.1 patient implanted with a gastric electrical stimulator (ges) underwent exploration due to a small bowel obstruction after lrygb.4.1 patient implanted with a gastric electrical stimulator (ges) that also underwent roux-en-y gastric bypass (rygb) experienced a complication.5.11 patients implanted with a gastric electrical stimulator (ges) experienced readmission.The most common indication for readmission was recurrence of gp-related symptoms (nausea, vomiting, and abdominal pain).6.1 patient implanted with a gastric electrical stimulator (ges) presented with sepsis secondary to wound infection and required re admission.7.1 patient implanted with a gastric electrical stimulator (ges) developed ketoacidosis secondary to dehydration and required readm ission.8.16 patients implanted with a gastric electrical stimulator (ges) required reoperation.No specific device information provided.

• Brand Name: NEU_ENTERRA_INS
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7117067
• MDR Text Key: 94829829
• Report Number: 3007566237-2017-05174
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_ENTERRA_INS
• Device Catalogue Number: NEU_ENTERRA_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2017
• Initial Date FDA Received: 12/14/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention