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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 07/08/2011
Event Type  Injury  
Event Description

It was reported by an ent surgeon that a vns pt was having dyspnea, paresis, and voice alteration. The voice alteration and paresis were occurring with vns stimulation and pt's vocal cords would get immobilized. However, her vocal cords would return to normal function after vns stimulation stopped. Additionally, the physician stated that at times, the pt's vocal cords get constricted so severely during the on times that it cuts off her breathing. This condition gets worse during exercise for pt. Pt has been having a great seizure control with vns therapy and would like to keep the vns turned on. The pt's generator's diagnostics were within normal limits on (b)(4) 2011. During (b)(4) 2011, pt complained that her throat was bothering her but did not want the setting lowered. During the next appointment on (b)(4) 2011, pt's settings, pulse width and frequency were lowered and pt's pain was resolved. Mfr received and reviewed the x-rays. The alignment of the positive and negative electrodes appeared to be normal. The lead was routed towards the generator. The generator was placed on the left chest and a small amount of lead was placed behind the generator. The connector pin could not be assessed since the generator was only partially visible in the x-ray images. However, the filter feed-thru wires appeared to be intact. Based on the x-ray images received, no obvious anomalies could be identified in visualized portion of the pt's vns device.

 
Manufacturer Narrative

Mfr reviewed x-rays of implanted device. X-rays reviewed by the mfr, no gross lead discontinuities visualized.

 
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Brand NameLEAD MODEL 304
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key2192435
Report Number1644487-2011-01707
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/08/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/01/2014
Device MODEL Number304-20
Device LOT Number204536
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received07/08/2011
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/01/2010
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: 07/27/2011 Patient Sequence Number: 1
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