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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL UNKNOWN GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL UNKNOWN GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 12/20/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient who had bronchitis did not tolerate vns stimulation well due to bradycardia occurring for the patient during stimulation on times. It was noticed during an eeg for the patient that the bradycardia occurred exactly every 3 and a half minutes which corresponded with the vns on time. It was advised to decrease the pulse width and frequency however it is not known if these changes were made. No additional relevant information has been received to date.

 
Event Description

This event was found to have been previously reported in manufacturing report # 1644487-2017-05093. The patient and device information was received confirming that the report in this file was a duplicate of the report. All further information regarding the events for the patient will be reported in manufacturing report # 1644487-2017-05093.

 
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Brand NamePULSE GEN MODEL UNKNOWN
Type of DeviceGENERATOR
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 Key7187658
Report Number1644487-2018-00076
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/08/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2018
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 Received01/16/2018
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: 01/12/2018 Patient Sequence Number: 1
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