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

Model Number 37800

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Electric Shock (2554)

Event Date 09/28/2023

Event Type  malfunction  

Event Description

The patient went in to see gi several months ago for refractory n/v.She was told that her settings were already very high, but the gi did adjust the settings per patient.For a few months she was fine.However for the past 2 two months, patient has been experiencing "surges".When occurring, she can time the surges every 8 seconds, but they come and go throughout the day or every couple days.She has seen her surgeon and the managing gi for these concerns.She saw her gi (dr.Kale) who thought after checking with programmer everything looked ok.Surgeon bruce smith placed the device but has since retired, so she recently saw dr (b)(6), who told her to go back to gi to have device interrogated.She has another telehealth appt today with gi at 2:45 cst.

• Brand Name: ENTERRA II IPG
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL, INC.; 5353 wayzata blvd. ste. 400; saint louis park 55416
• MDR Report Key: 18313110
• MDR Text Key: 330947927
• Report Number: 3027386225-2023-00026
• 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: 12/12/2023

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
• Device Operator: Health Professional
• Device Model Number: 37800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• 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: 56 YR
• Patient Sex: Female