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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNK

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CYBERONICS, INC. LEAD MODEL UNK Back to Search Results
Event Date 08/01/2006
Event Type  Injury  
Event Description

It was reported in a scientific article that a vns pt experienced decrease in appetite and coughing/choking on food after 1 month of vns therapy. These symptoms did not resolve despite reductions in vns stimulation parameters and the pt subsequently underwent placement of a gastrostomy feeding tube. The author reported that the symptoms seen in the pt may have been related to vns therapy, but in the physician's experience, these symptoms were more likely a result of the natural clinical history of rett syndrome.

 
Manufacturer Narrative

Article citation: wilfong, angus, and rebecca schultz. "vagus nerve stimulation for treatment of epilepsy in rett syndrome. " developmental medicine & child neurology (2006): 683-86. Print.

 
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Brand NameLEAD MODEL UNK
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste 600
houston , TX 77058
2812287200
MDR Report Key1552698
Report Number1644487-2009-02715
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/06/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/04/2009
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 Received11/06/2009
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: 12/04/2009 Patient Sequence Number: 1
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