MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ENTERRA; INTESTINAL STIMULATOR

Model Number 3116

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problems Unspecified Infection (1930); Internal Organ Perforation (1987); Hernia (2240)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 435135 lot# serial# (b)(6) implanted: (b)(6) 2010 explanted: (b)(6) 2023 product type lead product id 435135 lot# serial# (b)(4) implanted: (b)(6) 2010 explanted: (b)(6) 2023 product type lead.Other relevant device(s) are: product id: 435135, serial/lot #: (b)(4), ubd: 09-nov-2012, udi#: (b)(4); product id: 435135, serial/lot #: (b)(4), ubd: 09-nov-2012, 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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that when the patient was supposed to get a battery replacement in november and they found out that it wasn't working appropriately and said they think it was probably from the machine (later clarified that the machine wasn't helping their symptoms).Patient said that when they "got in there" the receptors that go to the stomach were embedded, it went through the lining, it was encapsulated and they thought it was infected.Patient said it had a lot of white cells but there were no germs and at the time he found that he cut the lead wires and cut the rest of it (full system) out.Patient said they did an "edg" and 2-3 weeks later they went back to see the hcp to retrieve the lead wires and the healthcare provider (hcp) could only get one out because the other one was so imbedded and so incapsulated and the doctor couldn't get it out.Patient said then they scheduled the replacement surgery in (b)(6) 2023 and the hcp said they would try to get the other wire "while we are in there" and the hcp was able to pull the old wire out and then found a hernia.Patient said the hcp fixed the hernia.When trying to clarify the machine not working appropriately and battery depletion, patient confirmed that each battery replacement was due to normal battery depletion.The patient's relevant medical history included patient mentioned they had a triangular esophagus.Patient also mentioned about 4-5 years after having the implant they had a big hernia and when they "got in there" to remove it, they found 6 hidden underneath it.Patient said they have diabetes and ended up with a feeding tube for about 3 months because they were losing weight and couldn't eat (patient confirmed diabetes caused this). patient mentioned they also have congestive heart failure from diabetes and the extra fluid may also have effected their symptoms.

Manufacturer Narrative

B2: corrected outcome attributed to adverse event as it was incorrect on the initial report.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.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; 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: 16252638
• MDR Text Key: 308240638
• Report Number: 3004209178-2023-01180
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00643169174993
• UDI-Public: 00643169174993
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2015
• Device Model Number: 3116
• Device Catalogue Number: 3116
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2023
• Date Device Manufactured: 05/22/2014
• 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; Life Threatening
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 38 KG