MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION ENTERRA; INTESTINAL STIMULATOR

Model Number 37800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Pain (1994); Malaise (2359); Electric Shock (2554); Insufficient Information (4580)

Event Date 06/02/2021

Event Type  malfunction  

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 and gastrointestinal/pelvic floor.It was reported that the patient had been implanted 8 days prior.They were experiencing pain, something that felt like shocking and it felt like they had a broken rib.They noted they did not have a managing physician.A courtesy message was sent to the field and the patient was redirected to a healthcare provider.

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.

Event Description

Additional information was received from a manufacturer representative (rep).The rep reported that the cause of the shocking was not determined.It was said that after speaking with the patient, the sensation is not consistent with the cycle (.1 sec on/ 4 sec off), so shocking is highly unlikely.The rep said that there is no way to make this determination when asked about most likely cause.It sounds like the patient is experiencing pain consistent with being 8 days post op.Many patient experience pain from surgery for up to 6 weeks.Steps taken were the rep spoke with the patient and she wanted to know where to go post-operatively for adjustments as needed.They discussed two different options closer to her home.Once the patient has confirmation of a post-op appointment, the stimulator will be interrogated to make sure the system is functioning as intended.The rep had spoken with the patient and will make sure they received post op management.The issue was confirmed resolved.

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 a manufacturer representative (rep).The rep reported that the patient had a follow-up appointment with dr.Simonian scheduled on (b)(6) 2021.

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 the manufacturer representative found a doctor for their device, as the doctor that put it in said they only implanted them, they did not manage them, but the representative never showed up to the appointment.The patient's partner called them and they said they did not work for the company anymore.The patient wished they never got the device.They felt like they had a constant electric shock, and had been sicker than they ever were before they had the device.They saw the doctor yesterday.The patient wanted to know who the representative was that covered this area.They were told an email to the district manager would need to be sent to find out because the previous representative was still listed on the roster.An email was sent to the field to request a representative in the area call the patient back, as the patient requested.The patient called back six days later repeating information previously reported in this case and stated that over a week ago, they met with their gastroenterologist and the manufacturer representative was supposed to meet with them at the healthcare provider appointment to set-up their device, but they were not at the appointment.They were informed the rep was no longer with the company.The patient's device was still not helping them any, and they were going to have to make another appointment with the doctor in a week to "set" the device, and needed a representative at that appointment.A follow up email was sent to the district manager for assistance locating a representative.The process for the healthcare provider to coordinate an appointment with a representative was reviewed, and the patient was provided with the national answering service (nas) phone number for their healthcare provider to request a representative.

Event Description

Additional information was received from the patient.The patient reported their ins has "zapped" them non-stop since they got it and stated "it's like being hit with a hot shot it's quite painful".The patient stated this is occurring even at the lowest setting and is not getting any better despite turning it up and down.The patient has tried different setting on the device and stated the last reset was on 2021-(b)(6).It hasn't been working well so far.The patient stated they have followed up with their hcp regarding this.The patient inquired on having the device removed.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.

• Brand Name: ENTERRA
• Type of Device: INTESTINAL STIMULATOR
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 7000 central ave ne; minneapolis MN 55432
• MDR Report Key: 11991052
• MDR Text Key: 255968265
• Report Number: 2182207-2021-01035
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000286798
• UDI-Public: 00763000286798
• Combination Product (y/n): N
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2022
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/14/2021
• Supplement Dates Manufacturer Received: 06/15/2021; 07/12/2021; 08/19/2021; 09/10/2021
• Supplement Dates FDA Received: 07/12/2021; 08/04/2021; 09/10/2021; 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 57