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

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Event Description

It was reported that the patient experienced difficulty breathing and became non-verbal when a magnet was placed over their chest.When the magnet was placed over the patient's chest again, they became responsive again.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Type of Device: STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 17531707
• MDR Text Key: 321090176
• Report Number: MW5138620
• 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: 12/03/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1