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

Model Number IPG 37800

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Nausea (1970)

Event Date 11/10/2023

Event Type  malfunction  

Event Description

Pt was in a vehicle accident.Shortly after she started having increased nausea and vomiting symptoms came in to get stimulator checked by dr.(b)(6).Dr.(b)(6) discovered that one of the leads was out of impedance range.So, they did egd/ x ray which gave no clear answer.So, they took her to the or to hopefully just do a battery change but ended up replacing the entire system.

• Brand Name: IPG 37800
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL; 5353 wayzata blvd, ste. 400; saint louis park MN 55416
• Manufacturer Contact: jane mammen
• MDR Report Key: 18312485
• MDR Text Key: 330297180
• Report Number: 3027386225-2023-00091
• 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: Non-Healthcare Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 12/11/2023

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
• 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): Required Intervention
• Patient Age: 36 YR
• Patient Sex: Female