MAUDE Adverse Event Report: ENTERRA MEDICAL, INC ENTERRA II IPG; GASTRIC STIMULATOR

Model Number 37800

Device Problem Material Puncture/Hole (1504)

Patient Problem Nausea (1970)

Event Date 01/01/2021

Event Type  malfunction  

Event Description

Phone call with patient on (b)(6) 2023, after patient reported/posted on social media (b)(6)2023 her experience with the et device and stated "i've had 3 [gastric stimulators].Unfortunately, it didn't help much for me.So when my gj tube got tangled with the leads, i had to have it removed, and had to pack the hole in my abdomen until it healed".This was originally reported to medtronic services, however, in an effort to gain further clarification, i reached out to patient to follow-up.On (b)(6) 2023, the patient states she was first implanted with enterra (b)(6) 2013 and did well.Her last battery replacement was (b)(6)2019.She had a gj tube placed in 2019 (unsure of date) and around the year 2021 (pt unaware of exact date) the j tube was found to have become entangled with the leads of the et device and became infected.This was found after completed x-rays and exam by dr.(b)(6) at (b)(6) university.He decided the et device needed to be fully removed, which occured in 2021 (pt unsure of date) and post-operatively, where the battery pocket itself remained, there was "hole" that was left and she needed to pack it and continue wound care measures until the area was healed, which took approximately 6 - 8 weeks.Pt states the et device helped decrease her acid reflux and nausea while she had it and asked about re-implant, however, was told by dr.(b)(6) that it was likely the leads would re-tangle again and that it was not an option for her.She continues to follow-up with dr.(b)(6) as needed.No further information provided.

• Brand Name: ENTERRA II IPG
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL, INC; 5353 wayzata blvd, ste. 400; saint louis park MN 55416
• MDR Report Key: 17997104
• MDR Text Key: 326411391
• Report Number: 3027386225-2023-00009
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 37800
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: 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: 48 YR
• Patient Sex: Female