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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 06/01/2010
Event Type  Injury  
Event Description

It was reported that a vns patient experienced a loss in appetite and vomiting after eating. The event began after recent full revision surgery that occurred on (b)(6)2010, but not until the device was programmed on. The event has been occurring since the device was programmed on by the md. There has been a medication change, which was a decrease in keppra as it was no longer needed after the vns device was programmed back on. The patient's device was programmed off by the treating neurologist for about a week and programmed back on. The events of vomiting and weight loss did not resolve when the device was off. Moreover, an examination was made by an ent and found the patient's esophagus to be inflamed due to unknown reason. Additional information was received from the ent physician indicating the patient was scheduled to undergo an endoscopy. Furthermore, follow-up was made with the ent which revealed there was no problem or issues visualized with the endoscopy. Biopsy samples were taken and results were normal. However, the ent did find a lot of secretion in the stomach. No stomach bleeding was observed other than the biopsy samples which is normal since the skin is being pierced. At this time, the ent could not assess the event of relationship to vns as he was waiting on a gastric emptying test. Good faith attempts to the treating neurologist at this time have been unsuccessful to date.

 
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Brand NameLEAD MODEL 304
Manufacturer (Section D)
CYBERONICS, INC.
houston TX
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1851110
Report Number1644487-2010-02209
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/31/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/30/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/31/2014
Device MODEL Number304-20
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received08/31/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/01/2010
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: 09/30/2010 Patient Sequence Number: 1
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