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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 06/08/2009
Event Type  Injury  
Event Description

It was reported in a scientific article that a vns pt presented via the emergency department following a series of six to eight seizures over 24 hours. The pt remained in an uncharacteristically protracted post-ictal state, and developed intermittent stridor associated with respiration embarrassment and hypoxia. Intercurrent vomiting episodes, coupled with widespread pulmonary crepitations, led to a provisional diagnosis of aspiration with laryngospasms. Treatment with continuous positive airway pressure ventilation, intravenous steroids and nebulised bronchodilators improved oxygen saturation, and normal consciousness returned. The stridor continues and was noted to be intermittent and not associated with desaturations. The pt was also noted to be aspirating on feeding. Furthermore, flexible laryngoscopy at rest revealed both vocal cords to be lying in a paramedian position during quiet respiration. During stridulous episodes, the glottis was noted to narrow further, with adduction of the left vocal and vestibular fold. It was suspected that vagus nerve stimulation was contributing to laryngeal dysfunction so the device was programmed off. Subsequent flexible laryngoscopy revealed a fully mobile left vocal fold but persistent right vocal fold palsy. At the moment, it is known that the vagus nerve stimulator remains programmed off and alternative medical therapy was initiated for seizure control. However, good faith attempts to obtain additional information have been unsuccessful to date.

 
Manufacturer Narrative

Article citation: bhatt, y. M. , and hans belloso. "airway compromise secondary to vagus nerve stimulator: case report and implications for otolaryngologists. " the journal of laryngology & otology 3rd ser. 1 (2009): 1-3. 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 Key1520362
Report Number1644487-2009-02460
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Literature,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 10/05/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/03/2009
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 Received10/05/2009
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: 11/03/2009 Patient Sequence Number: 1
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