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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 12/03/2012
Event Type  Injury  
Event Description

On (b)(6) 2012 clinic notes were received from a vns treating physician. Review of the clinic notes dated (b)(6) 2012 indicated that the patient has been having hoarseness and difficulty swallowing since the recent full revision surgery. The patient has clear dysphonia and increased weakness of the left arm. The physician reprogrammed the device at 0. 25ma and 0ma which did not change anything. The physician stated that he thinks this is just a postsurgical disturbance of the vagal nerve. They decided to turn the vns for two weeks and then have the vns turned back on in the hope that there will be some healing going on. The physician reported that the patient has damage to her vagal nerve and is experiencing vocal cord paralysis. Previously it had been reported that the patient was experiencing an increased coughing with stimulation after recent full revision surgery on (b)(6) 2012. Additional information was requested from the physician but the only further information he would provide was that he has still not seen the patient since the (b)(6) 2012 visit and that he did not believe she had seen an ear, nose, and throat (ent) physician.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS INC
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2904573
Report Number1644487-2013-00109
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/17/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/09/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2016
Device MODEL Number304-20
Device LOT Number202196
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/17/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/06/2012
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: 01/09/2013 Patient Sequence Number: 1
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