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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNKNOWN

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CYBERONICS, INC. PULSE GEN MODEL UNKNOWN Back to Search Results
Event Type  Injury  
Event Description

It was reported in the abstract for article entitled "effects of vagus nerve stimulation on electrocorticography" by kenichi usami, et. Al. That the pt experienced some reduction of seizure frequency and severity after one yr with vns. However, the pt also began experiencing "drop attacks" which had not been seen before. The pt subsequently underwent a total callosotomy.

 
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Brand NamePULSE GEN MODEL UNKNOWN
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1959460
Report Number1644487-2011-00005
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/07/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/06/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/07/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/06/2011 Patient Sequence Number: 1
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