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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS VAGAL NERVE STIMULATOR

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CYBERONICS VAGAL NERVE STIMULATOR Back to Search Results
Model Number 63850
Event Date 06/17/2013
Event Type  Injury  
Event Description

I had a vagal nerve stimulator implanted on (b)(6) 2010 at a hospital. The vns was to control irretraceable seizures from juvenile myoclonic epilepsy. From the time the vns was turned on, i experienced severe tightening of my throat, extreme hoarseness (usually laryngitis for several days after the vns was adjusted,) and stinging pain in my throat every time the device was sending electrical currents (approximately every 2 minutes). Beginning in (b)(6) 2013, my neck began to cramp when the vns would send the current and my seizures became more and more frequent. During the weekend of (b)(6) 2013, the side effects became so severe that i was having trouble breathing. My throat felt like it was closing up. During my routine neurologist visit on (b)(6), it was determined through diagnostic testing that my vagus nerve was not receiving any of the electrical stimulation the vns was sending out. The vns was immediately turned off and after an appointment with my neurosurgeon, i had revision surgery on (b)(6) 2013.

 
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Brand NameVAGAL NERVE STIMULATOR
Type of DeviceVAGAL NERVE STIMULATOR
Manufacturer (Section D)
CYBERONICS
MDR Report Key3305360
Report NumberMW5031542
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 08/19/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/20/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator
Device MODEL Number63850

Patient TREATMENT DATA
Date Received: 08/20/2013 Patient Sequence Number: 1
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