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

Model Number 3116

Device Problems Electromagnetic Interference (1194); Battery Problem (2885)

Patient Problems Diarrhea (1811); Nausea (1970); Pain (1994); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Anxiety (2328); Malaise (2359); Loss of consciousness (2418); Cognitive Changes (2551); Abdominal Distention (2601); Constipation (3274)

Event Date 02/06/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer (con) regarding a patient who was implanted with a neurostimulator for gastric stimulation.  it was reported gastric stimulation.   it was reported that patient has a funny feeling it is not working again/ therapy not working anymore because last week or so he has been so bloated and he had diarrhea again as his gastroparesis has gotten worse.Patient further stated that they noticed the symptoms since after the colonoscopy and endoscopy a couple weeks ago and they think the battery might be dead.Patient wants the mdt rep to come check his battery level at his doctor appointment in april.No further complications were noted or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from a consumer (con).It was reported that the patient didn't know if the device died, but they knew they were sick and had been for quite some time.They repeated they had a colonoscopy and an endoscopy and their doctor said they were all clear.The patient stated that no steps were taken to resolve the device being dead as they did not even know if it was dead.They stated they never had a relief of symptoms and it caused nausea, diarrhea, and vomiting.They also stated that they even passed out in their doctor¿s office.The patient had anxiety from the pain that they were experiencing and they had been constipated at times.

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.

Event Description

Additional information was received from the patient.It was reported that the patient made an appointment with a manufacturer representative (rep) to have the battery checked because they thought it was dead but the appointment never happened.They stated that over the last two months they have had nausea every single morning.The patient had tests done that showed diverticulitis.They stated gastroenteritis was strange and effected the whole body as well as mental health.The patient was redirected to a healthcare professional (hcp).No further patient complications were reported as a result of this event.

• 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
• MDR Report Key: 9764136
• MDR Text Key: 183142494
• Report Number: 3004209178-2020-04201
• Device Sequence Number: 1
• Product Code: LNQ
• 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,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR
• Patient Weight: 91