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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS PULSE GEN MODEL UNKNOWN GENERATOR

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CYBERONICS PULSE GEN MODEL UNKNOWN GENERATOR Back to Search Results
Event Type  Injury  
Manufacturer Narrative

 
Event Description

An article titled "vagus nerve stimulation inhibits cytokine production and attenuates disease severity in rheumatoid arthritis" was reviewed which included adverse event involving vns patient. It was reported that the patient presented bradycardia during the study. This adverse event was related to the implantation procedure.

 
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Brand NamePULSE GEN 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 Key5917241
Report Number1644487-2016-01964
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/31/2016
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? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/04/2016
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: 08/31/2016 Patient Sequence Number: 1
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