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

Model Number 3116

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

Patient Problems Diarrhea (1811); Nausea (1970); Therapeutic Effects, Unexpected (2099); Vomiting (2144); Weakness (2145); Therapeutic Response, Decreased (2271); Anxiety (2328); Malaise (2359); Weight Changes (2607)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The consumer reported on (b)(6) 2013 that they had a loss of therapeutic effect.It was noted that initially the therapy worked for the patient, but now it was not helping as much.The reporter stated that the patient thought it could be that he was getting older and the gastroparesis was progressing.It was reported that the patient had constant nausea and the patient¿s doctor¿s misdiagnosed him because he had intestinal issues on top of gastroparesis.The reporter stated that the patient¿s doctors thought that the patient¿s constant nausea could be because he had taken nexium for the past 14 years, and the patient thought that his intestines were the root of the problem.It was noted that cannabis was the only thing that worked on the patient¿s nausea.It was reported that the patient said that the stimulation system helped his body understand what to do, and his body could not get rid of water.It was noted that the patient did not take any oral medications for gastroparesis because had had been on so many medications over the years, no oral medications worked for him, and the side effects ¿were killing him.¿ the reporter stated that the patient couldn¿t take pain medications, the patient¿s diarrhea had always been bad, and the patient could ¿take imodium ad all day.¿ it was reported that the patient wanted the device battery checked, and the battery was last checked in (b)(6) 2013 and the patient was told that ¿it was fine¿ but the patient wanted to stay ¿on top of the therapy.¿ it was reported that the patient stated that the device ¿saved his life,¿ the patient was diagnosed with end stage gastroparesis, and the patient was dehydrated and found ¿passed out on the floor when he was initially diagnosed¿ in 2009.The reporter stated that the patient thought that he had gastroparesis since he was a kid and it just started getting worse.It was noted that the patient only ate one cup of food per day, and he wasn¿t sure how much longer he could handle the disease and only eating one cup of two kinds of food the rest of his life.It was reported if the patient ate the wrong food he felt pain for two to three weeks and had ¿major diarrhea.¿ it was noted that the patient had gained 14 pounds and the patient weighed (b)(6).It was reported that the patient needed a knee replacement but he couldn¿t because of his diagnosis and he couldn¿t take percocet.The patient was afraid to get the device removed.Additional information received from the consumer on (b)(6) 2013 reported that they believed that their implantable neurostimulator (ins) had helped with their nausea.It was noted that the patient had seen 25 doctors and that they used to take other drugs for their medical issues but now only took a zofran once in a while.The patient stated that their stimulation was turned down to almost zero.It was also reported that they ¿almost died¿ because of their gastric issues going from weighing (b)(6) but when they got the implantable neurostimulator (ins) and now weighed (b)(6).In addition, the patient noted that they needed a ¿total knee¿ and eye surgery.Additional information received from the consumer on (b)(6) 2014 reported that they still had diarrhea and nausea and vomiting and had had this since before the implant.It was noted that the ins never really helped the patient since implant with these problems.Additional information received from the consumer on (b)(6) 2015 reported that they were still sick.He does not know whether the implantable neurostimulator (ins) works or not.He was still getting nausea sometimes since implant.He was afraid to have the ins taken out because he did not have nausea all the time.He noticed it more when he ate greasy foods.If he ate a french fry, the oil would sit in his stomach and intestines and it would make him nauseated.Additional information received from the health care professional (hcp) on (b)(6) 2015 reported that it was unknown if the patient had a fifty percent or greater symptom reduction.The event cause was not determined.It was reported the patient was not seen on (b)(6) 2015.No troubleshooting or actions were taken.The patient experienced a loss of therapeutic effect and it was unknown if the loss was sudden or gradual.The patient status was unknown.Additional information received from the consumer on (b)(6) 2015 reported that there was a loss of therapy.The patient was in and out of the hospital all the time due to his condition.The patient had gastroparesis dehydration and continuous diarrhea all the time.This had been going on for years, prior to getting the implantable neurostimulator (ins), indicating that it was not caused by the device/therapy.The patient takes loperamide antidiarrheal medication every day and had for 4-5 years, however, it was starting to not work.The patient did not know if the ins was working or doing any good.He still had nausea, diarrhea, and retching.The emptying was fine now but it just empties.The patient could not do anything anymore and he was just miserable.He was taking lorazepam and benzodiazepine for anxiety.The patient could only eat 3 kinds of foods and nothing else.He ate the same food every day: boiled chicken, a piece of bread, and a little mayo.The patient was seeing a therapist and a psychiatrist and the illness was really bugging him to the point where his quality of life was poor.The patient was weak.The unit may have saved his life but it was counter productive from him because they know it worked.It was at the lowest settings it could possibly be at.They tried other settings and they did not work.A couple of weeks prior to (b)(6) 2015, the patient was so sick he thought he was going to die.He went to the emergency room, as he does all the time.The indication-for-use (ifu) was gastric stimulation.

Event Description

Additional information received from the consumer reported that they did not know if therapy was working or not.He still had the same symptoms, however, he also reported that he had gained 30lbs.The patient did not understand how this could happen since he had constant diarrhea.The patient goes to the emergency room twice a month due to dehydration and he was tired of doing so.The patient had systemic sclerosis and an autoimmune condition.The patient was considering going to see a psychiatrist after the holidays for an additional viewpoint.

Manufacturer Narrative

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 received from the consumer reported that the patient had gastroparesis, their intestines were shot, and they had diarrhea.The patient was never constipated.The patient got the device for their symptoms and the gastroparesis had gotten the best of them and they had waited 10 years for it to work, but they were getting sick of it.The patient was sick all the time and had been in and out of the emergency room (er) for it.The patient had not had a 50 percent or greater reduction in their symptoms.The patient never really had therapeutic benefit because nothing changed since implant on (b)(6) 2010.The patient currently had diarrhea.The patient was on the lowest setting that they could be on and maybe it needed to be changed, but they hadn¿t seen their health care provider (hcp) in 3 to 4 years.The patient also had pain at the stimulator site in the last 4 months beginning in 2016.Sometimes it was a sharp pain and the pain came and went.The patient hadn¿t had it for a week or so.The patient also mentioned they were on antidepressants, had anxiety, panic attacks, and depression.The patient was on an antidepressant ¿clanazopan.¿ the patient never had these symptoms before they got the device and it could be from the stress of being sick.It was 2011 or 2012 when this all started.The patient was going to consider going into a behavioral treatment center with psychiatrists for help.The symptoms were all ongoing and that the patient had a break somewhere in between, but was now experiencing them.The patient would follow-up with their hcp and make an appointment and intended to follow-up with a psychiatrist in a "behavioral outpatient program." the patient needed testing done because they had a sweating issue.It was not device related, but was drug related, due to the clarazopan and benzodiapeen they were taking.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5306930
• MDR Text Key: 33783700
• Report Number: 3004209178-2015-25222
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2011
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2016
• Date Device Manufactured: 11/10/2009
• 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): Hospitalization
• Patient Age: 00055 YR