MAUDE Adverse Event Report: CYBERONICS VAGAL NERVE STIMULATIOR; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY

Model Number 102

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Caller reported vagal nerve stimulator stopped working.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: VAGAL NERVE STIMULATIOR
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 17527794
• MDR Text Key: 321384756
• Report Number: MW5134725
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: 102
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1