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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 304-30
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 06/05/2017
Event Type  Injury  
Event Description

It was reported that the patient experienced constant hoarseness since her vns implant surgery. The patient was referred for vocal medialization surgery, and it was believed that the patient's vocal cord was possibly nicked during the implant. No further relevant information has been received to date.

 
Event Description

It was reported that there was no evidence of the vocal cord being nicked on evaluation by the ent. Left vocal cord paralysis (lateral displacement) with left arytenoid cartilage partial collapse. No surgery has occurred to date. If the surgery does occur, it was communicated that it will done for patient comfort only and not to preclude a serious injury. No further relevant information has been received 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 Key7282410
Report Number1644487-2018-00242
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/25/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/20/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL Number304-30
Device LOT Number203875
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/01/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/08/2016
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: 02/20/2018 Patient Sequence Number: 1
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