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

Model Number IPG 37800

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Neuralgia (4413)

Event Date 11/25/2023

Event Type  malfunction  

Event Description

Patient states she is running into some severe and random nerve pain near where the leads are set.

• Brand Name: IPG 37800
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): ENTERRA MEDICAL; 5353 wayzata blvd. ste. 400; saint louis park MN 55416
• MDR Report Key: 18313032
• MDR Text Key: 330939661
• Report Number: 3027386225-2023-00025
• 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: 12/12/2023

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: IPG 37800
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/12/2023
• 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: 31 YR
• Patient Sex: Female