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

Model Number 37800

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Nausea (1970)

Event Date 11/06/2023

Event Type  malfunction  

Event Description

After a gen change the patient has not been able to achieve the same level of efficacy.Unintended revision surgery to replace device.

• Brand Name: ENTERRA II IPG
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL, INC; 5353 wayzata blvd., ste 400; saint louis park MN 55416
• MDR Report Key: 18530133
• MDR Text Key: 333383935
• Report Number: 3027386225-2024-00002
• Device Sequence Number: 1
• Product Code: LNQ
• UDI-Device Identifier: 00763000449704
• UDI-Public: 00763000449704
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H990014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 21 YR
• Patient Sex: Female