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

Model Number 37800

Device Problems Intermittent Continuity (1121); Failure to Deliver Energy (1211); Energy Output Problem (1431); Pocket Stimulation (1463); Electromagnetic Compatibility Problem (2927); Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problems Undesired Nerve Stimulation (1980); Discomfort (2330); Insufficient Information (4580)

Event Date 07/01/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 4351-35, serial#: (b)(4), implanted: (b)(6) 2017, product type: lead.Other relevant device(s) are: product id: 4351-35, serial/lot #: (b)(4), ubd: 07-jan-2018, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative regarding a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation and gastrointestinal/ pelvic floor.It was reported that patient has reported to her physician back in (b)(6) 2021 that they were having involuntary stomach wall movements or "stomach waves" as the patient reported to them.Patient stated when  at home this occurs but not when they go to work or leaves the house.Patient indicated that a solar farm was installed (date unknown) next to patient's house.Rep didn't know distance from house to field where the solar farm is located.Date of when the "stomach waves" started is also unknown at this time.Patient reported that these waves are not uncomfortable and do not cause pain.There was mention that the polarity of the lead had changed from (b)(6) 2021 to (b)(6) 2021. so there is question as to if this was possible and caused by the solar field.Rep requested a follow up to be provided to rep for further discussions with patient and the hcp.No further patient complications are anticipated or expected as a result of this event.

Event Description

Additional information was received from the patient.They reported that the patient feels like the implanted device is acting erratically when the solar farm across from the home is generating power.The patient feels an "ill effect" the caller reported that the patient doesn't have any discomfort when at work or when she was away from home on vacation.The patient only experiences the effect when at home.Also at night when the solar system is not generating power the affect also goes away.The caller indicated that they measured for different potential sources of interference.The caller stated that they found no emi or emf and there was some rf in the millivolt range.The caller reported that they have the information provided by crhf about emi and rf interference and the rf levels were significantly below the values that crhf report as safe.The caller noted that the md described the polarity of the battery changing.The caller was not able to provide specific details about what the md was describing.Troubleshooting was not required.The issue was not resolved through troubleshooting.Tss reviewed information.The caller will direct the patient to follow-up with the managing md.No further complications were reported/anticipated at this time.

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

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: 2017-(b)(6) explanted: product type lead b3: date is estimated; month and year are valid.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), and healthcare provider via a manufacturer representative.The rep reported that this was previously reported, but they were driving and did not have the event information.They reported the patient lived near a solar farm and felt stimulation whenever they were at home, but they did not feel the stimulation when they were at work.The rep thought the patient felt stimulation in the ins pocket, but later said they were not sure where the patient felt the stimulation.The rep later reported they had called this in on 2022-(b)(6).They stated they were just "there" on friday, and the doctor asked about it again/if the rep had any thoughts about what they might try, since every time the patient would come home, they were feeling all the stimulation when they were in their house, but were totally fine when they were at work.They were not really sure, but it was something to do with an electromagnetic field that they believed the patient was reacting to.The rep told the doctor what the manufacturer help line said they should try.The rep stated it was this solar farm they guessed; they did not know.They stated ¿this is a different one,¿ but they had got to be generating energy and uploading it to a local power line.Something was going on within the patient or something in their house.

• 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: 12741031
• MDR Text Key: 279826320
• Report Number: 3004209178-2021-16322
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000286798
• UDI-Public: 00763000286798
• 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: Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2022
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/18/2022
• Date Device Manufactured: 08/24/2020
• 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...."
• Patient Age: 42 YR
• Patient Sex: Female