MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problems Disconnection (1171); High impedance (1291); Malposition of Device (2616); Insufficient Information (3190)

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

Event Date 11/23/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 4351 lot# unknown serial# product type lead.Other relevant device(s) are: product id: 4351, 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 multiple sources (manufacturer representative, healthcare provider) regarding a patient who was implan ted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient complains with the therapy results.There was no environmental issue noted.Impedance between spot 2 and 3 is quite high (3655 ohms).On (b)(6) 2022, x-ray was done : they saw a lead not correctly connected to the neurostimulator.They do not know if this connection issue was present at implantation or if it occurred after : in (b)(6) 2021, the neurostimulator was replaced without medtronic technical support.There was no action taken at the moment.  there was no surgical intervention that occurred. the issue was not resolved at the time of the report.

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.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 rep.They reported the cause of the lead placement issue had not been determined, it was unknown whether this issue had been resolved.The device was still in use at the time of the report.Rep had made outgoing attempts to obtain this information from the healthcare provider, however no response received at the time of report.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for unknown indications for use.It was reported that the patient was complaining about a malfunction of the pacemaker.Following their telephone conversation, they told them that a control x-ray should be performed, as the impedance values were too high.A 2volts, at c 1 2553 ohms, c 2 353 ohms, 2 3 5909 ohms: a 3 volts c 1 1606 ohms, c 2 347 ohms and 2 3 3655 ohms.No anomaly was found: the electrodes are in place and there is no disconnection of the cables at noted.It was noted on the image sent noted the end of one of the electrodes is not deep enough in the channel of the neurostimulator (circled in red on the attached x-ray): this explains why the impedances are abnormal between the battery © and pad 3 (+ make sure that the 4 screws are well screwed).In a second time, the impedances are also abnormal between studs 2 and 3, several hypotheses w ere suggested.

Manufacturer Narrative

Continuation of d10: product id 4351 lot# unknown 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

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 via the manufacturer representative.It was clarified the hcp did not request manufacturer support for the implant so it was unknown if there was a pre-op impedance check performed.Rep noted this is important and good practice, then further speculated that maybe the lead was not correctly connected to the neurostimulator during the implant procedure or maybe this connection lead issue occurred later after the implant.It is quite difficult to know because there was no manufacturer technical support for this implant and we do not know if the site performed this per-op impedance check.

Event Description

Additional information was received.The patient has contacted manufacturer for assistance to complaint because nothing had been done to solve the issue.It was recommended that the patient contact their healthcare professional (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.The rep reported that on (b)(6) 2023, the hcp contacted rep and has requested rep presence for a consultation with the patient.On 2(b)(6) 2023, the patient was seen by hcp and rep.Since the last follow-up, nothing was done by the hcp.The rep could only do again what they had already done when they saw the patient back on (b)(6) 2021.And rep could only repeat the technical advices they already provided before to hcp to solve the issue of the patient.Impedance test done again on (b)(6) 2023.Impedance tests have given the same results: the plot 2 is still not working.No difference has been identified between x-rays performed on (b)(6) 2023 and in august 2022.Nothing new, no evolution.Results of the impedance tests done on (b)(6) 2021 are as follows: at 2v: c 2 : 2553 ohms, c & 3 : 353 ohms, and 2 & 3 : 5909 ohms.At 3v: c & 2 : 1606 ohms, c & 3 : 347 ohms, and 2 & 3 : 3655 ohms.

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

Product id: 4351, lot# unknown, 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.On (b)(6) 2023, the patient came back to the operating room (or).The surgeon had scheduled an ipg replacement and requested a medtronic or technical support.They were surprised because the recommendation they had provided was to check in the or the connection between the leads and the ipg.Recommendation to replace the ipg was never advised.On (b)(6) 2023, when the patient arrived in the or, an impedance check was done.The results were the same as before, impedance out of range for c-2 and 2-3, and correct for c-3 (impedance > at 2000 ohms for c-2 and 2-3 and around 400 ohms for c-3).The surgeon opened the pocket, disconnected the 2 leads and reconnected them to the ipg.A per-op impedance check was done.Impedances were correct on all circuits (around 400 ohms for c-2 and c-3 and around 600 ohms for 2-3).This confirmed their hypothesis that the issue was coming from the lead number 2 which was not correctly connected to the ipg.The surgeon had scheduled an ipg replacement and decided to maintain it.The leads were disconnected from the ipg and connected to the new ipg.A per-op impedance check was done, the impedances were correct on all circuits (around 400 ohms for c-2 and c-3 and around 600 ohms for 2-3).

Manufacturer Narrative

Continuation of d10: product id 4351 lot# unknown serial# implanted: 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.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 15312854
• MDR Text Key: 305499858
• Report Number: 2182207-2022-01654
• Device Sequence Number: 1
• Product Code: LNQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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 H11...."
• Patient Outcome(s): Required Intervention
• Patient Sex: Female