MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Electromagnetic Interference (1194); Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Nausea (1970); Discomfort (2330); Electric Shock (2554)

Event Date 08/08/2021

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/ pelvic floor.It was reported that  the patient had difficulties with stimulator shocking her where pacer is at.Patient stated they can be doing nothing and it shocks them.It doesn't last long but it is just uncomfortable and she is curious on what can be done.Patient stated they say hcp, explained that they think it is malfunctioning but hcp keeps saying as long as the battery life is good they think it is fine.Hcp thought it could be a voltage problem.Shocks have been happening over a month or so now.Also the other day it did something when went through the device in the store and the alarm alarmed by the door and she didn't have anything in her hand.Patient said they did not have any falls or accidents.Patient said their device operates at high voltage or it doesn't work for them.Patient is still getting nauseated so they didn't want the hcp to turn down the voltage.Patient went to another hcp for a second opinion and they said the battery was ok.Patient wants to do an ed, upper endoscopy to check the wires.The patient said they both checked the battery and said the battery was ok.Technical services suggest running an impedance test and the patient thought they had run that test.Technical services explained to the patient they don't know what is causing the issue and they  would need to continue working with their doctor.If their hcp has questions on testing the stimulator system patient can call technical services.No further complications were reported at this time.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 12619040
• MDR Text Key: 277163986
• Report Number: 3004209178-2021-15250
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 10/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2019
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR