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

Model Number	37800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Electric Shock (2554)
Date of Event	06/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient states she has an enterra device in her stomach, and it's giving her extreme pain and she would like it removed today.Patient reporting side effects post implant.Patient reports that her stomach is giving her grief and she has been having aches, pains, jolts since her device was placed.She wants it out of her body asap.She reports that she has notified her hcp and that provider adjusted it first, then later turned it off.However, she reports that she continues to experience these symptoms.She has called for a follow up appt and states that she is scheduled for (b)(6) which is the earliest available.Encouraged patient to contact office to explain her symptoms and ask about sooner appt availability.

• Brand Name: ENTERRA II IPG
• Common Device Name: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL, INC.; 5353 wayzata blvd., ste. 400; saint louis park MN 55416
• MDR Report Key: 22718951
• Report Number: 3027386225-2025-00103
• Device Sequence Number: 18443164
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• Combination Product (Y/N): N
• PMA/510(K) Number: H990014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2025

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?: No
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 66 YR
• Patient Sex: Female