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U.S. Department of Health and Human Services

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

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CYBERONICS VAGAL NERVE STIMULATION SYSTEM; STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Convulsion/Seizure (4406)
Event Date 11/14/2013
Event Type  Injury  
Event Description
It was reported that a patient with a cyberonics vagal nerve stimulation system experienced a seizure on (b)(6) 2013.It was stated that the stimulation device is shut off.No additional information was provided regarding the event.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
VAGAL NERVE STIMULATION SYSTEM
Type of Device
STIMULATOR, AUTONOMIC NERVE, IMPLANTED FOR EPILEPSY
Manufacturer (Section D)
CYBERONICS
MDR Report Key17524559
MDR Text Key321135246
Report NumberMW5131505
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 01/29/2014
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
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/12/2023
Patient Sequence Number1
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