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	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient called the patient liaison line and left a voicemail stating, "i had an enterra therapy placed on (b)(6) and was doing fine but still feeling the stimulation.So went down the voltage a week and a half ago, few days later i sort of feeling the firing, the stimulation again.Put me on muscle relaxers a lot and i can't take that much.It's not helping, still feeling the stimulation and now i have a hard, like knot feeling, all around in my abdomen, around the pacemaker.It's pretty uncomfortable.I did place a call into the nurse at my surgeon's office waiting on a return call.I did have to call an on-call hospital doctor this weekend and they told me to call dr.(b)(6)." patient underwent an exploratory surgery on (b)(6) 2025 with dr (b)(6).She had a small seroma.The device was in the fluid.Dr (b)(6) tested the security of the leads, and they were still secure.He disconnected the leads and said there appeared to be fluid in the fluid in the header by the set screws.Dr (b)(6) cleaned out the pocket and then took gauze to clean out the header ports.He was unable to guarantee that all fluids had been removed, so he decided to replace the generator.The registration has been submitted.The old device was discarded and not returned.Patient complaint of feeling stimulation and overall discomfort; ipg ultimately replaced; explanted device discarded.

• 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: 22417387
• Report Number: 3027386225-2025-00083
• Device Sequence Number: 7137948
• 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: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/11/2025

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: 40 YR
• Patient Sex: Female