MAUDE Adverse Event Report: LIVANOVA USA, INC. VAGUS NERVE STIMULATOR (VNS) SYSTEM; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number M106

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2022

Event Type  malfunction  

Event Description

Request from device manufacturer for explanted, prematurely depleted vagal nerve stimulator.Working with vendor to get device back.

• Brand Name: VAGUS NERVE STIMULATOR (VNS) SYSTEM
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd.; houston TX 77058
• MDR Report Key: 16277066
• MDR Text Key: 308590492
• Report Number: 16277066
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: M106
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 4380 DA
• Patient Sex: Male
• Patient Race: Black Or African American