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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS GENERATOR MODEL UNKNOWN

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CYBERONICS GENERATOR MODEL UNKNOWN Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

An email was received from the head of therapy at the (b)(6) asking about a specific patient's side effects. The patient was having a loss of appetite, and discomfort, itching, and ringing in the ears with vns. The patient's symptoms reportedly stopped after the vns device was disabled.

 
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Brand NameGENERATOR MODEL UNKNOWN
Type of DeviceGENERATOR
Manufacturer (Section D)
CYBERONICS
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 Key6569006
Report Number1644487-2017-03817
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/16/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/16/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received04/21/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 05/16/2017 Patient Sequence Number: 1
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