MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

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

Patient Problems Abdominal Pain (1685); Nausea (1970); Vomiting (2144); Urinary Frequency (2275); Discomfort (2330); Malaise (2359); Electric Shock (2554); Paresthesia (4421)

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 friend/family member regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that they did not know the date, but they believed the stimulator had not been working for years, based upon the issues with trying to eat, they thought it had not been working for many years.They stimulator had been put in as part of a study.They stated that because it was not doing anything they thought it was probably not safe to keep in forever and they were looking for someone to remove it.They were redirected to their healthcare provider to address the issue.The patient had been reporting a lot of abdominal issues and pain that started about 2 months prior, which had been gradual and felt like a pin ching type of soreness, but had gotten a lot worse.They reported that at the same time the abdominal pain began, the patient began feeling like they had electricity running, like they were being zapped.

Event Description

Additional information was received from the patient.The husband doesn't feel they should have to pay for the removal when they were part of a research project.The last year or two they have been trying to get this device removed.They have had trouble finding a physician to remove it.They were in kansas and now have moved to florida.The stimulator has not been running for years at this point.They are getting increasingly sick and they don't know the cause.They are not sure if the device is disintegrating.Every couple weeks, 3-4 weeks they get nauseous.Very sick and wiped out.Bed ridden for 24 hours.It happens like every friday.Last week they were sick three different days.Device may not be the cause.The husband said it is like they have symptoms of lithium poisoning.They have frequent urination, tingling sensation, nauseous, and throwing up.They said it started a year to a year and a half back.

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 MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 12468113
• MDR Text Key: 271287271
• Report Number: 3004209178-2021-13792
• 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: Other,Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2010
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2022
• Date Device Manufactured: 10/24/2008
• 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 Sex: Female