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U.S. Department of Health and Human Services

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

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CYBERONICS, INC. PULSE GEN MODEL UNK Back to Search Results
Event Date 01/01/2007
Event Type  Injury  
Event Description

Manufacturer review of the presentation poster entitled "vagus nerve stimulation in children: twelve years of experience. Alving j, neilsen h, nikanorova m. " revealed a vns patient had increased seizures. Attempts to the author for further information have been unsuccessful to date.

 
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Brand NamePULSE GEN MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1595168
Report Number1644487-2010-00220
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/04/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/03/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received01/04/2010
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: 02/03/2010 Patient Sequence Number: 1
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