MAUDE Adverse Event Report: CYBERONICS - HOUSTON PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Convulsion, Clonic (2222); Irritability (2421); Confusion/ Disorientation (2553)

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported by the patient¿s mother to the physician that the patient had not been eating well and became ill after vns therefore it was requested that vns be turned off.The patient is now grabbing the device and scratching her chest a lot which is causing injury to the skin.During follow-up, the physician indicated that the cause for eating issues was not related to vns.The patient is autistic and is fixated on the generator site which is why they are itching.There is no injury to the skin and no swelling, just irritation from the patient touching it constantly.Clinic notes for the patient were received indicating that after vns was turned on initially, this would aggravate the patient more which had a tendency to worsen her seizures.The vns ended up being disabled after 3 months but was reattempted to be enabled for a week before it was turned off again.The patient has a tendency to obsess over the generator and pulls on it which irritates her skin.The patient currently does have magnet mode on for the longer prolonged seizures but this does not resolve the patient's concern regarding obsession of device and for this reason, the parents would like to have it removed.The patient had the device explanted but no product has been received to date.No additional relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Type of Device: GENERATOR
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12099566
• MDR Text Key: 259375487
• Report Number: 1644487-2021-00894
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/09/2017
• Device Model Number: 106
• Device Lot Number: 203667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/15/2021
• Initial Date FDA Received: 07/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2016
• 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: 9 YR