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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR

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CYBERONICS, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2018
Event Type  Injury  
Event Description

Patient's vns output currents were increased from about a month ago. Since that time, caregiver has noticed new events that when patient gets excited or laughing, he will suddenly fall to the ground and be limp for a short time. On initial discussion, this was thought to be a new seizure type or cataplexy but the nurse practitioner wanted to know if this could be a type of vasovagal event occurring when the device is stimulating. The nurse practitioner increased the device output current again with the thought the events could be seizures.

 
Event Description

It was reported that patient will suddenly fall to the ground and be limp for a short time whenever he is excited or laughs. These events are occurring at home and school ¿ specifically when going into his bedroom or certain place at school. There is no magnets or metal in door frames. Patient is able to move and does not lose consciousness. He just loses tone in legs and is laughing. It is unknown if patient has had dizziness or fainting episodes. There were no known medication changes. Patient does not have an history of these events except for the past couple of months. Patient does have a very complex medical history. The cause of patient's limpness in the leg was not determined. It was reported that there is no correlation known to vns therapy. Family does swipe magnet during the event and it seems to help.

 
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Brand NamePULSE GEN MODEL 103
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 Key7301451
Report Number1644487-2018-00296
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 03/27/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/27/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/06/2018
Device MODEL Number103
Device LOT Number5067
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/02/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/26/2016
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: 02/27/2018 Patient Sequence Number: 1
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