MAUDE Adverse Event Report: NTERRA MEDICAL, INC. IPG 37800; GASTRIC STIMULATOR

Model Number IPG 37800

Device Problem Unintended Movement (3026)

Patient Problem Implant Pain (4561)

Event Date 11/17/2023

Event Type  malfunction  

Event Description

Ablish with a new provider.Complains of pain/spasms at device site.He is concerned that the device or leads may have moved due to recent heavy lifting he did.

• Brand Name: IPG 37800
• Type of Device: GASTRIC STIMULATOR
• Manufacturer (Section D): NTERRA MEDICAL, INC.; 5353 wayzata blvd. ste 400; saint louis park MN 55416
• MDR Report Key: 18410393
• MDR Text Key: 331537440
• Report Number: 3027386225-2023-00035
• 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: 12/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Patient Age: 37 YR
• Patient Sex: Male