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

Model Number 37800

Device Problem Migration (4003)

Patient Problem Nausea (1970)

Event Date 02/19/2024

Event Type  malfunction  

Event Description

The patient responded to an email after completing a survey and in her email, she wrote, "i previously had 3 enterra over 5 years and each time the leads migrated." this patient responded to an email and wrote, "i previously had 3 enterra over 5 years and each time the leads migrated.So mine were removed, with the thought that my stomach needs to strengthen before another surgery can be done, and to wait at least a year, which would be (b)(6) 2024." "i am trying to determine if the enterra will be further help for me moving forward as my physicians have no other options for my nausea and i cannot keep anything down at this point.But the last one migrated immediately after surgery and was a problem right after it was put in, and i was in the hospital three months after it was put in and it was taken out two weeks later.I don't want to repeat the same thing." i attempted to call the patient to follow-up after receiving this email but there was no answer, and i left a voicemail.The last implant record for this patient in crm is an implant date of (b)(6) 2021 and the device serial number was (b)(6).

• 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: 18881856
• MDR Text Key: 337861408
• Report Number: 3027386225-2024-00020
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• 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: 39 YR