MAUDE Adverse Event Report: LIVANOVA USA, INC. SENTIVA; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 1000

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

The device was returned without paperwork or additional information.If you have any questions regarding this letter for manufacturer notification, please do not hesitate to contact us.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: SENTIVA
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): LIVANOVA USA, INC.
• MDR Report Key: 18694846
• MDR Text Key: 335404607
• Report Number: MW5151410
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1000
• Device Lot Number: 12695
• Patient Sequence Number: 1