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

Patient Problem Convulsion/Seizure (4406)

Event Type  Injury  

Event Description

The caller was a patient with a vagus nerve stimulator (vns).The caller requested magnets for their vns, noting that they had a seizure but could not find any magnets, which was "almost death" for them.Agent reviewed that the vns is not a mdt device and redirected the caller to livanova for further assistance.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: VAGUS NERVE STIMULATOR (VNS)
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 18913773
• MDR Text Key: 337917754
• Report Number: MW5152891
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/13/2024

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/14/2024
• Patient Sequence Number: 1
• Treatment: STIMULATOR, AUTONOMIC NERVE, IMPLANTED (DEPRESSION).