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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 06/22/2012
Event Type  Injury  
Event Description

Reporter indicated a patient developed dysphagia, hoarseness, and difficulty speaking following vns implant surgery on (b)(6) 2012. The patient was seen by an ent physician and was diagnosed with "paresis of the plica vocalis, left recurrent laryngeal nerve paresis, and gastroesophageal disease". The events are felt to be permanent and due to the vns implant surgery. The patient had no pre-vns history of the events. The vns was turned down to low settings, as the patient requested it not be disabled. The patient also received prednisone medication. The patient describes the events as "bearable". Intraoperative vns diagnostics were reported as "ok".

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD MODEL 304
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 Key2739617
Report Number1644487-2012-02281
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/14/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/11/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2015
Device MODEL Number304-20
Device LOT Number201934
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received08/14/2012
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/07/2011
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: 09/11/2012 Patient Sequence Number: 1
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