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

Model Number 37800

Device Problems Battery Problem (2885); Data Problem (3196)

Patient Problems Muscle Weakness (1967); Vomiting (2144); Dysphasia (2195); Ambulation Difficulties (2544)

Event Date 01/10/2023

Event Type  Injury  

Event Description

Information was received from a friend/family member regarding a patient (pt) who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that, about two weeks ago, patient experienced a return of severe gastroparesis symptoms and that a week ago tuesday caller took patient to the emergency room to received fluids as patient was so weak couldn't even move at that point, couldn't even hold down a capful of water.Caller said that the patient was hospitalized for five days.Caller said that hcp at hospital was not familiar with the therapy, doesn't have the equipment.And doesn't know anyone who has the equipment to check the patient's device.Caller said that the patient was discharged from the hospital on saturday and was redirected to managing hcp of their implant.Caller said that patient's symptoms have not improved, said that the patient is unable to hold down water, food and can't talk.Caller said that they called the managing patient's long-term gastroenterologist and the office said that the earliest the patient can be seen is in april.Caller said that they called the implanting physician, however said they don't have the equipment and tried a new hcp, however they were told that they aren't taking new patients at this time.Caller is concerned due to patient's current physical state that might not make it.Caller is concerned that there may be an issue with the battery and would like to have the device checked as soon as possible.The patient was redirected to their healthcare provider to further address the issue, for medical attention.An urgent email was sent to local medtronic representative.Caller also mentioned that the setting have changed by itself in the past, however unable to find any previous calls regarding this event. pt called back on (b)(6) 2023 and wanted to know the status of a call back from a rep.Pt reported the same therapy issue and stated they did end up seeing their gi doctor last night.Pt stated the doctor agreed to have the rep come to their location to have the device checked.Pt services agreed to send another message to the representative to notify them of the additional call from the pt.

Manufacturer Narrative

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.

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 (hcp).They stated that it was unknown if the battery issue was caused by normal battery depletion.The issue was not resolved but no further action will be taken.The cause of the settings changing by themselves was unknown.When asked what steps were taken to resolve the issue, they reported the patient left their practice and chose someplace closer to home.

• 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: 16262365
• MDR Text Key: 308346406
• Report Number: 3004209178-2023-01232
• 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
• Report Date: 04/20/2023

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: 01/28/2023
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/24/2023
• Initial Date FDA Received: 01/30/2023
• Supplement Dates Manufacturer Received: 04/07/2023
• Supplement Dates FDA Received: 04/21/2023
• Date Device Manufactured: 08/02/2021
• 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): Hospitalization
• Patient Age: 39 YR
• Patient Sex: Female