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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS VNS VAGUA NERVE STIMULATOR

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CYBERONICS VNS VAGUA NERVE STIMULATOR Back to Search Results
Lot Number 686260
Event Date 01/06/2012
Event Type  Injury  
Event Description

On the morning of (b)(6), i woke up with a shocking feeling in my head, accompanied by a migraine. When it didn't subside by monday the (b)(6), i decided to email the company that makes my vns, cyberonics. On tuesday the manager called me back and after telling him everything that was happening, he said to turn the device off and see if i still have the shocking feeling by taping my magnet to my vns for a few hours. After taping the magnet to the device, although the shocking went away, my skin started feeling like it was on fire. After removing the magnet a few hours later, the shocking feeling and migraine came back immediately, and there as a burn mark on my chest where the device is. Then on wednesday the (b)(6) i had to be taken to the hosp by ems for severe chest pains. The feeling still hasn't gone away. Frequency: on 30 sec off 1. 5 min.

 
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Brand NameVNS
Type of DeviceVAGUA NERVE STIMULATOR
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd.
houston TX 77058
MDR Report Key2423729
Report NumberMW5023856
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 01/13/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/13/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT Number686260
OTHER Device ID Number0143
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No

Patient TREATMENT DATA
Date Received: 01/13/2012 Patient Sequence Number: 1
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