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

Model Number 37800

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Nausea (1970)

Event Date 03/01/2023

Event Type  Injury  

Event Description

Patient called the patient liaison line and left a message.I called her back and she was asking about mri.We discussed mr conditional labeling.She said she had enterra therapy implanted in 2019 and had to have it removed in (b)(6) 2023 due to needing a brain mri due to seizure history.The patient states she had a lot of success with enterra therapy and since having the device removed, she has had nausea and vomiting that is not controlled with medications.The patient was looking for information on additional providers that work with enterra therapy.She states dr.Abodeely removed her last device and was looking for a provider closer to her.She was interested in dr.(b)(6) and scheduled a consultation.She had to check with her insurance to see if he would be in-network.The appointment was scheduled for (b)(6) 2024.Patient requested an email with the next 2 closest enterra therapy provider incase her insurance told her dr.(b)(6) was not in network.

• Brand Name: NTERRA 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: 18366112
• MDR Text Key: 331009971
• Report Number: 3027386225-2023-00032
• 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: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2023
• 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
• Is the Reporter a Health Professional?: Yes
• 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: 45 YR
• Patient Sex: Female