MAUDE Adverse Event Report: ENTERRA MEDICAL IPG 37800; GASTRIC STIMULATOR

Model Number IPG 37800

Device Problem Intermittent Shock/Stimulation (2287)

Patient Problem Nausea (1970)

Event Date 10/06/2023

Event Type  malfunction  

Event Description

Patient recently resumed nausea and vomiting symptoms.Pa adjusted setting, increasing voltage to 9.A few days later, patient called back complaining of shocking feeling.Symptom based algorithm for stimulator settings sent to physician.

• Brand Name: IPG 37800
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL; 5353 wayzata blvd. ste 400; saint louis park 55416
• MDR Report Key: 18311332
• MDR Text Key: 330287943
• Report Number: 3027386225-2023-00024
• 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: Other Health Care Professional
• 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

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: IPG 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