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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS NEUROCYBERONIC PROSTHESIS VAGUS NERVE STIMULATOR

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CYBERONICS NEUROCYBERONIC PROSTHESIS VAGUS NERVE STIMULATOR Back to Search Results
Lot Number 300-20-17644
Event Date 01/10/2010
Event Type  Injury  
Event Description

X-ray showed excessive scar tissue at the electrode site. A sonogram revealed that the scar tissue has built up to a point where it is compressing the carotid artery, restricting blood flow. My dr seems very concerned and is weighing her options. Dates of use: (b)(6) 2000 - (b)(6) 2006.

 
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Brand NameNEUROCYBERONIC PROSTHESIS
Type of DeviceVAGUS NERVE STIMULATOR
Manufacturer (Section D)
CYBERONICS
houston TX
MDR Report Key1994994
Report NumberMW5019425
Device Sequence Number1
Product CodeLYJ
Report Source Voluntary
Reporter Occupation PATIENT
Type of Report Initial
Report Date 02/13/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/13/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device LOT Number300-20-17644
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Is this a Reprocessed and Reused Single-Use Device? No

Patient TREATMENT DATA
Date Received: 02/13/2011 Patient Sequence Number: 1
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