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

Model Number 37800

Device Problem Failure to Deliver Energy (1211)

Patient Problems Nausea (1970); Pain (1994); Vomiting (2144)

Event Date 03/14/2020

Event Type  Injury  

Event Description

(b)(6) 2022, (b)(4)(con): information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that patient received a new ins battery implanted in 2020.Patient had reported that shortly after implantation, they were having pain under their ribs and said it was like starting from zero.Patient also stated they had pain on their stomach where they were getting nauseous, they wouldn't eat and symptoms had increased.Patient said they had monthly appointments with their gastroenterologist and they were also calling in between appointments because they were throwing up so many times during the day.Patient said they were throwing up and had "all the normal symptoms" and the symptoms did not improve.Patient said during an appointment, the managing doctor tried "moving the enterra", performed testing and found out that the device was turned off and said "that's why you're having these problems." patient said after the doctor changed the battery, their gastroenterologist said the device wasn't doing what it was supposed to be doing.Patient said the implanting doctor was able to turn on the implant and checked the battery and the battery was fine, but patient said "my body wouldn't go back to normal." patient said they were still experiencing pain on their left side and "it was the lead for the machine, it was hurting and couldn't find out what it was.".Patient said their implanting doctor checked and said the machine turns on and off by itself even though the device was disconnected from their body and other organs (due to stomach removal surgery- unrelated).Since they removed the patient's stomach, the device was obsolete.Patient stated the doctor said it would be best to have the device removed because "it wasn't doing anything there." patient believes the ins (battery and leads) was completely removed in july 2022, and "know it was after the 4th of july." at this time, explant information is not up to date.

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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15553945
• MDR Text Key: 301344417
• Report Number: 3004209178-2022-12987
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169614246
• UDI-Public: 00643169614246
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/03/2022
• Date Device Manufactured: 11/11/2019
• 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: 53 YR
• Patient Sex: Female