MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS; INTESTINAL STIMULATOR

Model Number NEU_INTERSTIM_INS

Device Problem Low Battery (2584)

Patient Problems Hypoglycemia (1912); Therapeutic Response, Decreased (2271)

Event Date 10/02/2017

Event Type  Injury  

Manufacturer Narrative

Date of event.Please note that this date is based off of the date that the article was accepted for publication 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_interstim_ins, lot# unknown, product type: implantable neurostimulator.The main component of the system.Other relevant device(s) are: product id: neu_interstim_ins, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Laine, m., siren, j., koskenpato, j., punkkinen, j., rantanen, t., typpo, i., kokkola, a., sallinen, v.Outcomes of high-frequency gastric electric stimulation for the treatment of severe, medically refractory gastroparesis in (b)(6).Scand j surg.2017.Doi: 10.1177/1457496917748222 summary: severe, medically uncontrollable gastroparesis is a rare entity, which can be treated using a high-frequency gastric electric stimulator implanted surgically.Previous follow-ups have proven positive outcomes with gastric electric stimulator in patients with gastroparesis.The aim of this study was to evaluate the efficacy and safety of gastric electric stimulator in patients, in whom gastroparesis could not be controlled by conservative means in our country.This is a retrospective multi-center cohort comprising all patients who had been implanted gastric electric stimulator for severe, medically refractory gastroparesis during 2007¿2015 in (b)(6).Fourteen patients underwent implantation of gastric electrical stimulator without any postoperative complications.Laparoscopic approach was used in 13 patients (93%).Prior implantation, all patients needed frequent hospitalization for parenteral feeding, 13 had severe nausea, 11 had severe vomiting, 10 had notable weight loss, and 6 had frequent abdominal pain.After operation, none of the patients required parenteral feeding, 11 patients (79%) gained median of 5.1 kg in weight (p¿<(><<)> 0.01), and symptoms were relieved markedly in 8 and partially in 3 patients (79%).Of partial responders, two continued to experience occasional vomiting and one mild nausea.Five patients needed medication for gastroparesis after the operation.One patient did not get any relief of symptoms, but gained 6 kg in weight.No major late complications occurred.Gastric electrical stimulator seems to improve the nutritional status and give clear relief of the symptoms of severe, medically uncontrollable gastroparesis.Given the low number of operations, gastric electrical stimulator seems to be underused in finland.Reported events: interestingly, symptoms slowly recurred during control visits in four patients.It was found out that their ges battery was exhausted.These patients underwent battery-change reoperation.For one patient, this was done twice.Battery-change restored the functionality of the stimulator and relieved the symptoms in all four patients.No surgical complications were related to reoperations.One patient with diabetic gastroparesis continued to have hypoglycemic episodes needing hospital treatment.No specific device information was provided.

• Brand Name: NEU_INTERSTIM_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: 7339336
• MDR Text Key: 102439174
• Report Number: 3007566237-2018-00780
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2018

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?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INTERSTIM_INS
• Device Catalogue Number: NEU_INTERSTIM_INS
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/14/2018
• 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; Required Intervention