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

Model Number 37800

Device Problems Disconnection (1171); High impedance (1291); Unstable (1667); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190)

Patient Problems Nausea (1970); Vomiting (2144)

Event Date 11/07/2022

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of the system and other applicable components are: product id neu_unknown_lead lot# unknown serial# implanted: explanted: product type lead section d information references the main component of the system.Other relevant device(s) are: product id: neu_unknown_lead, serial/lot #: unknown.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 healthcare provider regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that patient had a knee replacement(unrelated) 4 months ago and mri at the time of surgery.Patient stated that they now have returned of  nausea and vomiting since that time requiring to additional hospitalizations.Egd and ct scan was done and lead wires were not visible.Patient will undergo a surgery for evaluation.

Manufacturer Narrative

Continuation of d10: product id 4351-35 serial# (b)(6) implanted: (b)(6) 2021: product type lead product id 4351-35 serial# (b)(6) implanted: (b)(6) 2021: 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.

Manufacturer Narrative

Continuation of d10: product id 4351-35 lot# serial# (b)(6) implanted: (b)(6)2021 product type lead product id 4351-35 lot# serial# (b)(6) implanted: (b)(6)2021.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 healthcare provider (hcp).The hcp reported the device remains implanted.They were uncertain the cause of the lead not being visible on the egd or ct, noted lead 2 was loose in the housing and could be removed with gentle traction.Once replaced they insured the impedance dropped.Additional clarification was received from the healthcare provider (hcp).They verified current implant information and said the leads were not replaced, but re-secured into the header block of the ins, a revision had occurred.They stated that the leads were visible and normal/expected course from the generator to the gastric wall was noted.The reason the leads were not seen on the egd was that it was not intraluminal on egd.The ct was of abdomen/pelvis with no contrast.Patient's surgical history was asked, the hcp noted there had been no mesh placements.Patient had kidney and pancreas transplants, colectomy, fistula takedown, c-section and cholecystectomy.It was noted the patient had a history of bowel obstruction.The cause of the lead being loose in the housing had not been determined, it was noted that the patient reported violent/persistent emesis after their knee surgery for many days.

Manufacturer Narrative

Continuation of d10: product id 4351-35 lot# serial# (b)(6) implanted: (b)(6)2021 explanted: product type lead product id 4351-35 lot# serial# (b)(6) implanted: (b)(6)2021 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

Additional information was received.They further reported that when physician went in to do a revision and found the leads to be di sconnected from the ins header and he reattached and the patient improved.They thought the patient's description of their violent episodes of vomiting was enough torque to pull the leads out of the header.

Event Description

The patient reported that they have another knee replacement surgery coming and wanted to see if their is anything they should tell the medical professionals before their surgery or what to do and not do.The last time they had knee surgery something happened with their device where they regressed back to their former state of condition prior to implant.They also reiterated the issue with the wires coming undone and also mentioned they "do not know how it flipped over the abdominal wall".The patient indicated that they struggled post surgery with significant post-op nausea/vomiting/dry heaving the cause of the wires ¿coming undone and the stimulator flipping¿.This has all since resolved and patient is doing well.The patient was directed to their device managing physician to inquire about questions regarding upcoming surgery.

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 MN 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 16108322
• MDR Text Key: 306779573
• Report Number: 2182207-2023-00031
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• 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,Followup,Followup
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/28/2023
• Date Device Manufactured: 08/09/2021
• 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: 58 YR
• Patient Sex: Female
• Patient Weight: 63 KG