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

Model Number 37800

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Electric Shock (2554)

Event Date 01/24/2024

Event Type  malfunction  

Event Description

Patient reports a shocking felling and or flutter around the stimulator.Unkown if there has been any trauma.It was reported as random in nature.Impedance levels were all normal.Provider to lower the stimulation and have the patient call back in a week to report.Provider also mentioned that the patient has a bmi of 46 and the generator changes position when the patient moves.Friends of the patient think they can see the abdomen flutter when the patient reports having this feeling.Investigation and follow-up with patient and provider revealed that patient was involved in a car accident and experienced trauma in the abdominal area.She also fell and hit her abdominal area.Impedance is in range and the trauma is believed to be the cause of the discomfort and not the 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: 18784220
• MDR Text Key: 337417891
• Report Number: 3027386225-2024-00014
• Device Sequence Number: 1
• Product Code: LNQ
• 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: 01/31/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/26/2024
• 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