MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 105; GENERATOR

Model Number 105

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

Patient Problems Chest Pain (1776); Pain (1994); Neck Pain (2433)

Event Date 08/16/2017

Event Type  Injury  

Event Description

It was reported that the patient woke up one day and was experiencing severe pain in the chest and neck.There was no known trauma to the vns and the neurologist didn't know what the cause was.The patient's settings were lowered and x-rays were ordered.Clinic notes indicated the patient patient's mother had called and reported that the patient was having severe chest pain and the patient was given fentanyl en route.A chest x-ray was unremarkable.A neurologist disabled her normal mode output current.Post pain medications and device disablement , the pain went away with no recurrence.The pain appeared to be prominently in the left side of the chest but also went into her neck and lower trunk region.The patient's mother indicated that the patient's pain was cyclical.There was no recent trauma to the head, neck and chest, and no patient manipulation.When the vns was turned on to 0.5 ma the patient began to experience pain again, and her device was re-disabled.It was believed that the patient's pain was related to stimulation.The patient's device was reportedly working properly with good impedances.The physician believed that the patient's generator and leads may need to be replaced.The pain was reported to be serious.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The patient's generator and lead were replaced.The explanted products were discarded.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 105
• 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: 6858790
• MDR Text Key: 85799376
• Report Number: 1644487-2017-04442
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 11/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/20/2016
• Device Model Number: 105
• Device Lot Number: 203181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2014
• 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: 19 YR