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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/19/2018
Event Type  Injury  
Event Description

It was reported that the patient developed swallowing difficulties following a lead and generator replacement surgery due to the vns surgical procedure. The patient's generator was turned on immediately after their vns replacement surgery. It was indicated that the patient's device had been turned off to allow for wound healing and that the physician prescribed steroids for post-operative healing. The device disablement and steroids were for patient comfort. It was additionally reported that the patient underwent surgery due to "vocal cord issues. " both the swallowing and vocal cord issues were attributed to the vns replacement surgery. No additional relevant surgical intervention has occurred to date. No further relevant information was received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8120818
Report Number1644487-2018-02172
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number204551
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/08/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/19/2018
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: 11/30/2018 Patient Sequence Number: 1
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