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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 07/06/2009
Event Type  Injury  
Event Description

It was reported that a vns patient experienced a decrease in mobility of the left vocal cord along with aspiration and difficulty swallowing three months post implant. The patient was evaluated by an ent physician who identified a positive vocal cord paralysis. Additional information received from the ent revealed the relationship of the vocal cord paralysis to vns is unknown. Good faith attempts to obtain product information have been unsuccessful to date.

 
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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 Key1445192
Report Number1644487-2009-01746
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/20/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/19/2009
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 Received07/20/2009
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: 08/19/2009 Patient Sequence Number: 1
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