MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number NEU_INS_STIMULATOR

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

Patient Problems Feeding Problem (1850); Complaint, Ill-Defined (2331)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

Literature citation: shada a, nielsen a, marowski s, helm m, funk lm, kastenmeier a, lidor a, gould jc.Wisconsin's enterra therapy experience: a multi-institutional review of gastric electrical stimulation for medically refractory gastroparesis.Surgery.2018;16 4(4):760-765.Doi: 10.1016/j.Surg.2018.04.043 a2: this value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the sex of the majority of the patients reported in the article as specific patients could not be identified.Please note this date is based off of the article¿s online publication date as the specific event date was not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the reported events 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_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Other applicable components are: product id: neu_ins_stimulator, serial/lot #: unknown, ubd: asku, udi#: asku.If information is provided in the future, a supplemental report will be issued.

Event Description

Literature summary: the authors sought to evaluate the outcomes of gastric electrical stimulation (ges) in the state of wisconsin during a more than 10-year period.A total of 119 patients received gastric electrical stimulation therapy (64 diabetic and 55 idiopathic).The authors ultimately concluded that ges therapy led to the improvement of symptoms of gastroparesis and a better quality of life.Patients were able to decrease the use of prokinetic and narcotic medications and achieve long-term satisfaction.Reported events: 1.4 patients had a new feeding jejunostomy tube placed after the initiation of gastric electrical stimulation (ges).It was noted the additional procedures were gastroparesis related.2.2 patients underwent a pyloroplasty after the initiation of ges.It was noted the additional procedures were gastroparesis related.No further complications were reported or anticipated.See attached literature article.

• Brand Name: ENTERRA
• 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: 8419287
• MDR Text Key: 138763276
• Report Number: 3007566237-2019-00613
• 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: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2019
• 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): Required Intervention
• Patient Age: 45 YR