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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 10/12/2012
Event Type  Injury  
Event Description

It was initially reported that the patient had severe hoarseness since date of implant, and there was consideration at that time to refer the patient to ent for botox injection in the vocal cord area due to possible laryngeal nerve damage. Upon follow-up, it was reported that the patient saw the ent on (b)(6) 2016. The ent noted that the patient had an underlying sleep breathing disorder. The ent discussed that the patient had left vocal paresis that was likely due to the vagal nerve stimulator implant. The ent assessed that given that he is not having significant problems with his voice or airway, the ent recommended observation. Per the reported diagnostics, the device is functioning properly. It was also noted that the patient recently had a tonsillectomy and adenoidectomy, in which the left vocal cord paralysis was initially noted. No additional relevant information has been received to date.

 
Event Description

It was reported that the patient's treating medical professional did not think the vocal cord paralysis was related to the vns as the vns surgery had occurred some time ago. No additional relevant information has been received, to date. No known surgical intervention has occurred to date.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key6064969
Report Number1644487-2016-02481
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Followup
Report Date 10/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/28/2016
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 Number3182
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/09/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/23/2011
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: 10/28/2016 Patient Sequence Number: 1
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