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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 01/01/2004
Event Type  Injury  
Event Description

Reporter indicated via the published journal article "vagus nerve stimulation therapy: 2 year prospective open label study of 40 subjects with refractory epilepsy and low iq who are living in long-term care facilities. Epilepsy and behavior 2005; 6:417-423. Huf, roger, et al. " that a newly implanted vns pt developed a new seizure type (cluster seizures). All attempts for additional info from the reporter have been unsuccessful to date.

 
Manufacturer Narrative

Article citation: vagus nerve stimulation therapy: 2 year prospective open label study of 40 subjects with refractory epilepsy and low iq who are living in long-term care facilities. Epilepsy and behavior 2005; 6:417-423. Huf, roger, et al.

 
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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 Key1488715
Report Number1644487-2009-02176
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/01/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2009
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 Received09/01/2009
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: 09/30/2009 Patient Sequence Number: 1
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