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

Model Number 3116

Device Problems Break (1069); Unintended Collision (1429); Energy Output Problem (1431); Electromagnetic Compatibility Problem (2927); Positioning Problem (3009)

Patient Problems Nausea (1970); Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  Injury  

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 the patient (pt) experienced a fall last wednesday and broke their pelvis and knee.The caller stated that the pt had surgery and as of friday has been experiencing nausea and stomach problems.Caller states they would like to have a representative come to the medical center where the pt is staying to check the pt's device to see if it's still on.The caller was redirected to pt services provided nas number for healthcare provider to reach out to the representative.

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

Continuation of d10: product id: 4351-35, lot# serial# (b)(6), implanted: (b)(6)2014, product type: lead, section d information references the main component of the system.Other relevant device(s) are: product id: 4351-35 model, serial/lot #: (b)(6) , ubd: 2015-09-18, udi#: (b)(4).Product id": 4351-35, lot# serial# (b)(6), implanted: (b)(6)2014, product type: lead, section d information references the main component of the system.Other relevant device(s) are: product id: 4351-35 model, serial/lot #: (b)(6) , ubd: 2015-10-24, udi#: (b)(4).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 received from patient.They reported they saw an x-ray following their fall for the first time last week.The x-ray showed there were pieces of the ins and lead wire all over the place in pieces.Patient reported their hip joint area in particular "is like a junk yard".Patient alleged there are wires all over the place and the ins is cracked and pieces of the battery all over the place.Patients managing physician refused to treat them.

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

No new information.

Manufacturer Narrative

Continuation of d10: product id 4351-35 lot# serial# (b)(6) implanted: (b)(6) 2014 product type lead product id 4351-35 lot# serial# (b)(6) implanted: (b)(6) 2014 product type lead 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 the caller called back and reported the same information.The caller indicated that the original fall was not far or at a high rate of speed, they just "slid off" a piece of exercise equipment.The caller discussed damage to their leg and the need for 3 surgeries on leg and stomach as a result of the fall.Caller indicated the x-rays show a "junk yard" of pieces inside of them with the bulk of it being in the hip.The caller indicates that they have contacted all of the doctors on the listings we provided, but none want to help.The caller indicates that they are looking to have the pieces removed and to be implanted with another device because they currently have their gastroparesis back and want the relief that the therapy provides.The caller indicates that they are willing to travel if needed.Emailed reps to see if there are other opt ions for hcps to help the patient.The caller added that her hcp does not want the patient to have anesthesia for 6 months, and that this physician will surgically remove the pieces then if needed, but they do not want to and they are not familiar with the device and will not put a new one in.Emailed manufacturer representatives to see if they are aware of any options for the patient.

Event Description

Additional information was received from the patient.Patient called back and repeated device situation.Patient stated they haven't been able to find any hcp to remove it and would like to know what are all the possible concerns that could occur by leaving the system in their body, in its current state.Patient said they are becoming very frustrated and did mention that will contact their attorney to start proceedings if information isn't provided to them.Patient said they haven't spoken to the representatives as they are playing phone tag.

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

Continuation of d10: product id 4351-35 lot# serial# (b)(6) implanted: (b)(6) 2014 explanted: product type lead product id 4351-35 lot# serial# (b)(6) implanted: (b)(6) 2014 explanted: product type lead 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

The patient was supposed to have replacement surgery next tuesday; however found out the facility still doesn't have the product.Patient said doesn't want the surgery postponed and wants product sent via fedex asap.Patient said is very frustrated and has spoken about it to their attorney.Patient services explained that the local representative needs to be contacted.Patient said would like an update as soon as possible.Re-opened case to send another email.Patient called back for an update and wanted to provide their cell number.Another email was sent to field staff to request update and provided patient's cell number(number listed on record).Patient said their device was supposed to be replaced today and is rescheduled for (b)(6) 2023.Patient said they spoke to 2 manufacturer representatives (rep), both of which were supposed to call the patient back and didn't.Patient said they have left 3 messages for one rep and 1 for the other rep.Patient said they want to confirm product will be available on (b)(6)2023.Patient said they have spoken to the ceo before and if they don't hear back from someone today they will contact ceo.Emailed manager.

• 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: 14434276
• MDR Text Key: 292037748
• Report Number: 3004209178-2022-06366
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup,Followup,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2023
• Date Device Manufactured: 09/27/2013
• 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
• Treatment: "SEE H10...."; "SEE H10...."; "SEE H10...."; "SEE H10...."
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Weight: 61 KG