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

Model Number 103

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Seizures (2063)

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.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• 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 Key: 7301451
• MDR Text Key: 101113901
• Report Number: 1644487-2018-00296
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750030
• UDI-Public: 05425025750030
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/06/2018
• Device Model Number: 103
• Device Lot Number: 5067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 10 YR