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

Model Number 37800

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Nausea (1970); Pain (1994); Seroma (2069); Vomiting (2144); Burning Sensation (2146); Swelling/ Edema (4577); Insufficient Information (4580)

Event Date 04/15/2022

Event Type  Injury  

Manufacturer Narrative

Event date: date is estimated; year is 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

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastric stimulation.It was reported that after their battery replacement they had some burning going on, and when they told their physician, patient was told there was fluid.About a month after that, the patient did a virtual visit and told the doctor the pacemaker was moving, and the doctor said it could not move.The patient would feel the ins move when bending over to tie their shoes.The stimulator is on their right side and the ins site is extremely puffy.The stimulator is now moving when standing or sitting not just bending over.The device pushes out from under the skin.Patient will push on their stomach to try to put it back in place.It is now getting to the point where it is getting stuck out of place.Patient was in the hospital for a week nauseous and vomiting.They took a cat scan which showed erosion and then they changed their mind and said there was not erosion.Patient thinks they did something wrong during the replacement surgery and realized it and are now trying to cover up for that.This surgeon cut above where the pacemaker was and patient thinks she might have cut the pocket.Patient ended up following up with managing physician who said they would replace it.  the patient said they are prone to infection, but they have been feeling the ins site and it is not warm, and patient feels like there has to be fluid there.Patient has had 2 cat scans done and the doctor said according to the cat scans there is no fluid.Patient suspects there to be fluid because it feels like the device is floating when it moves, is swollen and it is starting to become painful.The device is visible when looking at the stomach and sticks out.During the call with patient services patient took a call from their physician's office who was calling to notify patient that replacement surgery is scheduled for thursday.Patient was happy with this news and ended the call.

• 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: 15277322
• MDR Text Key: 298416562
• Report Number: 3004209178-2022-10732
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/23/2022

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: 04/14/2023
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 08/23/2022
• Date Device Manufactured: 10/19/2021
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female