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

Model Number	37800
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Failure of Implant (1924); Unspecified Infection (1930)
Date of Event	04/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
From the call center: i am calling about a battery replacement for a neurostimulator.Patient felt device wasn't helping and had it replaced; ended up with infection of new device which was then explanted to allow infection to resolve.
Additional Manufacturer Narrative
The patient was scheduled for an enterra device replacement at (b)(6) for (b)(6) 2025.(b)(6) hospital was not able to provide us with their irb approval letter in time to send product.Patient's case was to be rescheduled for later in may.Patient called me last night and was upset because she was leaving for a three week trip to (b)(6) to be with her daughter who is graduating from nursing school.Patient asked if there might be an implanter in (b)(6) who may be able to help her.She reached out to dr.(b)(6) at (b)(6) and was able to schedule an appointment for (b)(6).Follow up call information: patient is scheduled for an appointment with dr.(b)(6) on (b)(6) for evaluation and to be seen before scheduling her battery change.Patient had her enterra battery changed with dr.(b)(6) on (b)(6) 2025.Spoke with (b)(6) on (b)(6) 2025.(b)(6) mentioned that her device pocket became infected and that her device was scheduled to be removed on (b)(6) 2025.Device was disposed of on (b)(6) 2025 when it was exchange by dr.(b)(6).

• 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: 22372709
• Report Number: 3027386225-2025-00075
• Device Sequence Number: 12755463
• 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: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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: 07/01/2025
• Supplement Report FDA Received Date: 07/23/2025
• 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 Sex: Female