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 Pain (1994); Post Operative Wound Infection (2446)

Event Date 07/19/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable component: 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

Arthur, l.E., slattery, l., richardson, w.Tailored approach to gastroparesis significantly improves symptoms.Surg endosc.2017.Doi: 10.1007/s00464-017-5775-7 summary: gastroparesis is difficult to treat and many patients do not report relief of symptoms with medical therapy alone.Several operative approaches have been described.This study shows the results of our selective surgical approach for patients with gastroparesis.Materials and methods this is a retrospective study of prospective data from our electronic medical record and data symptom sheet.All patients had a pre-operative gastric emptying study showing gastroparesis, an esophagogastroduodenoscopy, and either a ct or an upper gi series with small bowel follow-through.All patients had pre- and post-operative symptom sheets where seven symptoms were scored for severity and frequency on a scale of 0¿4.The scores were analyzed by a professional statistician using paired sample t test.Results 58 patients met inclusion criteria.Thirty three had gastric stimulator (ges), 7 pyloroplasty (pp), 16 with both gastric stimulator and pyloroplasty (gsp), and 2 sleeve gastrectomy.For patients in the gsp group, the second procedure was performed if there was inadequate improvement with the first procedure.There was no mortality.The follow-up period was 6¿316 weeks (mean 66.107, sd 69.42).Ges significantly improved frequency and severity for all symptoms except frequency of bloating and postprandial fullness.Pp significantly improved nausea and vomiting severity, frequency of nausea, and early satiety.Symptom improvement for gsp was measured from after the first to after the second procedure.Gsp significantly improved all but vomiting severity and frequency of early satiety, postprandial fullness, and epigastric pain.Conclusion all procedures significantly improved symptoms, although numbers are small in the pp group.Ges demonstrates more improvement than pp, and if pp or ges does not adequately improve symptoms gsp is appropriate.In our practice, gastrectomy was reserved as a last resort.Reported events: for the gastric stimulator only group one patient experienced pain at the stimulator site and had to have their stimulator removed a year after original placement.For the group who underwent gastric stimulator placement as their second operation, a patient experienced a superficial wound infection.No specific device information was 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: 6985178
• MDR Text Key: 90582731
• Report Number: 3007566237-2017-04596
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/27/2017

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
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 10/27/2017
• 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): Other; Required Intervention