MAUDE Adverse Event Report: CYBERONICS VAGUS NERVE STIMULATOR

Model Number 106

Device Problem Device Stops Intermittently (1599)

Patient Problem Respiratory Distress (2045)

Event Date 06/06/2016

Event Type  Injury  

Event Description

Abrupt onset of excessive stimulation that produced shortness of breath "choking sensation".When the magnet was permanently placed over the device, the stimulation did not stop but became intermittent.Dates of use: (b)(6) 2013 - (b)(6) 2016.Diagnosis: epilepsy.Event abated after use: yes.

• Brand Name: VAGUS NERVE STIMULATOR
• Type of Device: VAGUS NERVE STIMULATOR
• Manufacturer (Section D): CYBERONICS
• MDR Report Key: 5735726
• MDR Text Key: 47824369
• Report Number: MW5062906
• Device Sequence Number: 1
• Product Code: LYJ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/15/2016

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
• Device Operator: No Information
• Device Model Number: 106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/15/2016
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR
• Patient Weight: 54