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 Codes	Abdominal Pain (1685); Failure of Implant (1924)
Date of Event	04/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
From the call center: i don't know if my battery in my stimulator is low or not, i need to make arrangements to see if the battery should be replaced.I take nausea medicine, zofran but it's not working this week.Id # (b)(6).Patient had battery exchanged.Explanted battery was disposed of therefore no analysis possible.No further action to be taken.
Additional Manufacturer Narrative
Patient complaint of discomfort and battery flipping.Patient revised and explanted device disposed of onsite.No analysis possible.No further action to be taken.

• 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: 22413124
• Report Number: 3027386225-2025-00082
• Device Sequence Number: 8293662
• Product Code: LNQ
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H990014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2026

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
• Operator of Device: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2025
• Supplement Report FDA Received Date: 07/08/2026
• 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 Sex: Unknown