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

Model Number 3116

Device Problems Battery Problem (2885); Insufficient Information (3190)

Patient Problems Wound Dehiscence (1154); Dehydration (1807); Diarrhea (1811); Nausea (1970); Pain (1994); Paresis (1998); Vomiting (2144); Malaise (2359); Ambulation Difficulties (2544); Weight Changes (2607); Constipation (3274); Insufficient Information (4580)

Event Date 01/01/2012

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 patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that the system worked for two years and then he was put on medication.  and did not think  they had full mobility  and  was constipated.Caller thinks it was the medication that helped.They put him on zofran.Patient has nausea, vomiting, diarrhea, pain.After two years the patient started to get sick again.  patient has gastroparesis, but he doesn't think it is gastroparesis,  and has had  gastroparesis,  and thinks the stimulator is impeding.Patient has had a lot of different elements since the system has been put in.Patient has a scar from sternum to navel that is where the doctor cut him open.They said they were going to do lathrosopy and didn't.The  incision broke open two weeks later and they had to put mesh.Patient  was (b)(6) pounds when  started and down to (b)(6) and keeps going down more.Patient can't have grease.Patient said  they have   flare ups.  patient wants to get the battery checked to see if it is dead or alive.Patient has an appointment with the doctor october 18.Patient wants to know if  they  can leave the system in or does it have to be removed.Caller also wanted to know if the new system allows for the patient to have their own handset.Agent did not ask about the circumstances that led to the reported issue.   patient wanted to know if they would replaced the lead  and was told  it depends on if they feel it is working and in the right place.No further complications were reported/anticipated at this time.

Event Description

Addition information with patient calling back because the group that updated their address wanted to transfer them to report a problem with their stimulator.Patient said, they do not plan to fix the problem.Patient said since implant enterra has never helped, they still had nausea vomiting diarrhea and has been in the hospital over 60 time's for dehydration.Patient said when it was implanted it was a botched surgery and the surgeon has left the country.Patient said it was supposed to be laparoscopic but the doctor cut their whole chest open from the sternum to the navel, implanted the unit to the right of navel with wires on the right and left sides of the stomach but patient had ventral hernia that busted open in the next couple of weeks.Patient said, the doctor put in some mesh and the patient had nothing but problems since them.Patient said they had to have it done they were really bad they couldn't eat, couldn't sleep, couldn't go to the bathroom couldn't throw up.Couldn't do anything.Patient said, enterra saved their life or maybe god saved their life.Patient said after surgery patient was really sick then they sent him home the next day in a snowstorm.Patient said they think their natural body rhythm and the unit are fighting each other, their body wants to make the stomach move and (pt did not clarify further).Patient said when they need things done like adjustments they need to drive for 2 hours but can't drive to the market, they cannot get the medtronic tech to check it.Patient said they would like a way to control their stimulator to make adjustment on their own.Patient asked if rep could meet at gastro apt.Patient wishes he could adjust stim by himself.Patient stated the device should be turned on for the first 2 years then shut off to 'see what happens'.Patient said their unit does not work and the battery will die soon.

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.Patient said they had the device checked and found out the ins is almost dead.Patient said they have had the device adjusted numerous time and was told the ins would last 10 years which is a lie.Patient said they have been so sick for the past 4 years and they found other ways to make the patient feel better.Patient said the device may work for other people but it never really worked for the patient.Patient said the helped some in the beginning.Patient the device didn't work well for them.Patient said people should have other test before getting the device.No further complications were reported.

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.

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.Pt called back repeating previously reported event in this case.Pt reported they went to the hospital and saw their managing hcp and was told that their implant battery is "limping along" and is almost dead.Pt stated they haven't noticed a difference because pt's setting were down to "almost zero".Pt reported they have had problems as previously reported in this case regarding nausea and vomiting.Pt reported they lost weight due to having diarrhea all the time.Pt stated they had some therapy adjustments made.Pt reported they "don't think it's the pacer" because since pt has stopped taking their blood pressure medication they have lost so much weight they have been feeling great.Pt stated since they are feeling great they want to leave ins implanted even though their ins is depleted (pt stated ins has been dead for a couple weeks or longer) and inquired if there is concern with leaving ins implanted despite being depleted.Troubleshooting reviewed therapy/implant considerations/overview.Redirected pt to hcp to discuss.Pt stated they have been at the lowest setting and have gone up and down a little for the past 10 years "and it was fine".Pt stated all of a sudden they are not sick at all and they think as soon as they stopped taking their blood pressure medication their underlying condition (gastroparesis) has improved.Pt stated they were previously at 245 lbs and now they are down to 159 lbs.Pt also stated they need to see a nutritionist because they have to eat a restricted diet and cannot have any oil, grease or sugar.Pt stated they are on phenazepam (pt stated it's a benzodiazepine).Pt stated they are on this medication due to anxiety from "of all the pain that was going on" (pt did not clarify this statement).Pt stated they think it will take time to get off this medication.Redirected pt to hcp to discuss.Pt inquired if enterra is no longer managed by medtronic.Reviewed overview of management/manufacturing of enterra.Pt inquired if there is an enterra system with a controller.Reviewed enterra therapy overview.Pt made a comment at the end of the call that they have "seen children go through this mess".Pt then stated they had to go and agent was unable to clarify this statement.

Event Description

Additional information was received.The patient called back, reiterating previously reported information and stated that a week after they went to see their hcp at temple where the hcp had done a check on the unit and it was determined that the battery life was "up" and it was "just barely moving," it died and the patient started getting really sick again.The patient stated they've learned to control the illness by taking medications like pepto bismol, but they couldn't keep taking these medications for the rest of their life (they even had side effects from the pepto bismol) and they were working with their hcp to get the unit replaced.The patient stated they were so sick they'd rather be a guinea pig for any clinical tests being done.Patient services redirected the patient back to their hcp.

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.They reported that in 2010 the patient was told their device would last 10 years and it only lasted 7 years.They have been going through hell and been sick the last three years.They said the company needs to tell patients how long the stimulator batteries actually last.Patient said they have no mobility and have constipation.They are having surgery done to have the stimulator battery replaced in (b)(6).They have their preop in (b)(6).

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: 12601217
• MDR Text Key: 276492006
• Report Number: 3004209178-2021-15102
• 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,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2021
• 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: 12/01/2022
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male
• Patient Weight: 72 KG