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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 07/06/2017
Event Type  Injury  
Event Description

It was reported through a study adverse event form that a patient's vns was disabled due to laryngospasms. The severity of the laryngospasms was marked as severe and life-threatening. No clarification as to why the event was considered life-threatening has been received to date. As a result of this event, the patient discontinued the study. After the vns was disabled, the problem resolved. No further relevant information has been received to date.

 
Event Description

It was reported that a patient in a study had experienced laryngospasms with stimulation. It was reported that the reason that they were considered life-threatening was because they were a danger to the airway and causing breathing difficulties. There was no prior history or other factors that could have contributed to the event. System diagnostics of the device were within normal limits. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key7290396
Report Number1644487-2018-00263
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/22/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/22/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/17/2017
Device MODEL Number106
Device LOT Number4524
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/23/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/25/2015
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: 02/22/2018 Patient Sequence Number: 1
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