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

Model Number 37800

Device Problem Overheating of Device (1437)

Patient Problems Bruise/Contusion (1754); Erythema (1840); Pain (1994); Increased Sensitivity (4538); Alteration in Body Temperature (4568)

Event Date 03/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: 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.

Event Description

Information was received from a patient who was implanted with an implantable neurostimulator (ins) for gastrointestinal/pelvic floor therapy.It was reported that the reason for the call was to ask about adverse events with the implant.Patient said that, in march, they noticed some redness and bruising underneath the neurostimulator, however they said that it went away.About a month ago or so, patient had a real bad lupus flare up (said experienced high temperatures of about 105 degrees and followed sepsis protocol) and then noticed seeing redness and bruising right below neurostimulator.They said that it looks like a huge red line following the curve of the neurostimulator.Patient said that the neurostimulator site is extremely hot, said took temperature and the ins site was 102 degrees whereas the other side of stomach was 97 degrees.Patient also said that, in march, the neurostimulator site became very sensitive to any touch, very painful, and then that subsided, however started up again about four weeks ago and is extremely painful.Patient said that the pain is so severe that patient is taking pain medication, opioids, every single day.Patient said they're used to the pain due to their medication conditions, however said that this pain at neurostimulator site is the worst pain they've ever experienced.Patient said they've been hospitalized twice in the past three weeks, for five days at a time, said was just disc harged on december 1st.Patient said that they did see their managing hcp at the hospital last week and discussed the situation, however they feel stuck.Patient said, based on their expertise, hcp doesn't believe that the neurostimulator is contributing to patient's medical symptoms and doesn't recommend having the system removed as the therapy has really helped managing patient's gastroparesis symptoms.Agent reviewed adverse events which patient confirmed has also viewed on the website and wondering if could be tissue damage, cellulitis.Patient said that they also saw and consulted with other specialists while admitted to the hospital: rheumatologist, infectious disease, gi and hospitalist.Patient said that they all concurred to consider leaving implant for now.Patient said was scheduled to have system removed, however decided to cancel and wait because the therapy itself has helped with management of gastroparesis symptoms.The patient was redirected to their healthcare provider to further address the issue.Patient said respects and is pleased with current doctor.Please note that patient does not want managing physician notified of call.The patient mentioned unrelated medical history.This included that they've had an extremely severe case of lupus and other medical conditions.Patient said that hcp is retiring in may.Agent offered to search for other physician listings, patient declined and said that their managing hcp is looking for other motility specialists for the patient.

• 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: 16085969
• MDR Text Key: 306507724
• Report Number: 3004209178-2023-00022
• Device Sequence Number: 1
• Product Code: LNQ
• 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: 01/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 37800
• Device Catalogue Number: 37800
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/08/2022
• Date Device Manufactured: 02/05/2020
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female