MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

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

Patient Problems Unspecified Infection (1930); Pain (1994)

Event Date 08/28/2019

Event Type  Injury  

Manufacturer Narrative

Literature citation: zoll b, jehangir a, edwards ma, petrov r, hughes w, malik z, parkman hp.Surgical treatment for refractory gastroparesis: stimulator, pyloric surgery, or both? journal of gastrointestinal surgery.2019.Doi: 10.1007/s11605-019-04391-x.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 acceptance 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.Other applicable components are: product id :3116, serial#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: 3116, serial/lot #: unknown, ubd:(b)(4) , udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Literature summary: the article set out to compare the clinical outcomes of gastric electric stimulation (ges), pyloric surgery (ps) such as pyloromyotomy or pyloroplasty, and simultaneous ges+ps for refractory gastroparesis (gp).The authors found that patients with refractory symptoms of gp undergoing ges, ps, or combined ges+ps each had significant improvement of their gcsi total score.Ges and combined ges+ps significantly improved nausea/vomiting.These results suggest ges or combined ges+ps appears better for nausea/vomiting predominant refractory gp.Reported events: 1.1 patient had their gastric stimulator removed for infection.2.1 patient had their gastric stimulator removed for severe pain.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: 9497773
• MDR Text Key: 172416948
• Report Number: 3007566237-2019-02582
• 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: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2019
• 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: 40 YR