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	Failure of Implant (1924)
Date of Event	12/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient initially called patient liaison phone line to report return of n/v symptoms and burning.Patient was advised to follow up with her health care provider.Enterra medical followed up with patient and provider, patient had device explanted (b)(6) 2025.Explanted device disposed of therefore analysis not possible.No further action to be taken.
Event or Problem Description
Patient reports that she was implanted on (b)(6) 2022 by dr (b)(6).States she has been having recurrence of symptoms and burning near device site.She denies having a device card and no implant record found in crm.She plans to f/u with surgeon.Patient explanted due to discomfort and return of n/v symptoms.

• 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: 22650370
• Report Number: 3027386225-2025-00089
• Device Sequence Number: 12961464
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: H990014
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2025

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
• Operator of Device: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 07/29/2025
• 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: 60 YR
• Patient Sex: Female