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	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Information received by enterra sales rep from a physician.The patient reported experiencing shock at the site of lead insertion.Surgeon and patient opted for a full explant and decided not to reimplant due to the patient being on low settings and no longer needing the device, with no symptoms of gp.Explanted device was disposed of therefore no analysis possible.No further action to be taken.
Event or Problem Description
Shocking at leads site.The patient reported experiencing shock at the site of lead insertion.Surgeon and patient opted for a full explant and decided not to reimplant due to the patient being on low settings and no longer needing the device, with no symptoms of gp.

• 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: 22648884
• Report Number: 3027386225-2025-00094
• Device Sequence Number: 8763010
• 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 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): 07/08/2025

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: 06/30/2025
• 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: 69 YR
• Patient Sex: Male