MAUDE Adverse Event Report: ENTERRA MEDICAL, IINC. ENTERRA II IPG; GASTIC STIMULATOR

Model Number	37800
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient states her enterra therapy battery died.She states symptoms got worse the 3rd week of march when she started vomiting constantly.She states she spent the last week in the hospital.She states her battery is only lasting about 1 year due to high settings per patient.She states she is a patient of dr.Kurian who is retiring, but states she is working with another provider in the office who is working on a preauthorization for replacement surgery.Patient was transferred to tech services.Patient experienced return of n/v symptoms due to battery depletion; battery replaced; explanted ipg was disposed of.No further action to be taken.

• Brand Name: ENTERRA II IPG
• Common Device Name: GASTIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL, IINC.; 5353 wayzata blvd., ste. 400; saint louis park MN 55416
• MDR Report Key: 22413622
• Report Number: 3027386225-2025-00088
• Device Sequence Number: 15876170
• 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
• 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): 06/30/2025

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: Not provided
• Initial Report FDA Received Date: 07/07/2025
• 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: 61 YR
• Patient Sex: Female