MAUDE Adverse Event Report: Enterra Medical Enterra Gastric Stimulation System; Gastric Stimulator

Model Number	30101
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Waiting for return of lead; pending analysis.
Event or Problem Description
Fraying of the prolene suture - during the procedure, while the surgeon was passing the lead through a 12 mm trocar, he noticed that the needle remained inside the trocar after the lead had entered the abdominal cavity.Upon inspection, the prolene suture was found to be frayed and had separated from the needle.The trocar was a 12 mm trocar with the backstop removed, and there were no apparent obstructions that could have caught the lead.The surgeon was using the same laparoscopic needle driver and technique that he has routinely used in prior cases to pass the lead sutures/discs through the trocar into the abdominal cavity.No changes had been made to the instruments or technique.The same needle driver was subsequently used to pass the remaining two new leads without any issues.The affected lead was never implanted into the patient.Once the damage was identified, the lead was removed from the sterile field and replaced with a new lead.The replacement lead was implanted successfully without further issues.The patient was not affected by the event.

• Brand Name: Enterra Gastric Stimulation System
• Common Device Name: Gastric Stimulator
• Manufacturer (Section D): Enterra Medical; 5353 wayzata blvd; suite 400; st. louis park MN 55416
• Manufacturer Contact: laura bauer ; 5353 wayzata blvd; suite 400; st. louis park, MN 55416
• MDR Report Key: 50482790
• Report Number: 3027386225-2026-00108
• Device Sequence Number: 21360337
• Product Code: LNQ
• UDI-Device Identifier: 00850045965204
• UDI-Public: 00850045965204
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 30101
• 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: 07/30/2026
• Initial Report FDA Received Date: 08/27/2026
• 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: Unknown