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

Model Number	37800
Medical Device Problem Codes	High impedance (1291); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient went to see provider because nausea symptoms had returned.Originally implanted in (b)(6) last (b)(6).Impedance was out of range and patient stated that she had been doing a lot of heavy lifting recently.Surgeon scheduled her for a possible lead/ battery revision.Went in and changed the battery.Patient returned back to normal impedance range.Patient is to follow up with surgeon in 2 weeks.
Additional Manufacturer Narrative
Patient had battery replacement due to return of symptoms.Impedance out of range.Patient is doing fine with new battery.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: 22322833
• Report Number: 3027386225-2025-00069
• Device Sequence Number: 8812446
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2025

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
• Is the Reporter a Health Professional?: 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: 06/24/2025
• Supplement Report FDA Received Date: 09/09/2025
• 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: 33 YR
• Patient Sex: Female