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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 03/28/2017
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that the patient stopped eating since the vns stimulation off time was changed from 5 minutes to 3 minutes. Due to the shorter off time, the auto stimulations per day also decreased from 120 to 80 as the physician expected. No other reasons are known for patient's behavior. As a result, the physician changed the off time back to 5 minutes approximately 48 hours after she stopped eating to see if the patient's behavior will return to baseline. Neurologist hasn't heard back from patient yet regarding improvement. The decrease in patient's appetite is believed to be due to vns stimulation. System diagnostics were run twice, and both were reported to be ok.

 
Event Description

Additional information was received from the neurologist that the patient is doing better.

 
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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 Key6514969
Report Number1644487-2017-03661
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/15/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/23/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/03/2018
Device MODEL Number106
Device LOT Number203767
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/08/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/20/2016
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: 04/23/2017 Patient Sequence Number: 1
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