MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 106; GENERATOR

Model Number 106

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

Patient Problems Muscle Spasm(s) (1966); Neck Pain (2433)

Event Date 02/06/2017

Event Type  Injury  

Event Description

The patient was experiencing a painful shocking feeling in his neck at the lead site that occurred with every stimulation.The device was disabled using the magnet.The next day, the painful stimulation returned and the patient was also experiencing an increase in seizures and his neck appeared to be pulsing at the site of the lead.The patient¿s school nurse attempted to disable the generator with the vns magnet however this did not inhibit stimulation.Due to the pain, the patient was taken to the surgeon to have the device programmed off.The surgeon performed diagnostic testing and x-rays and it was reported that everything seemed ok.Further follow-up found that a week prior to the pain and muscle spasm events, the generator¿s settings were increased as a part of normal titration.The physician later reported that the seizure rate was the same as pre-vns baseline and that the settings were still being titrated so the patient had not yet reached efficacious settings.The physician also confirmed that the magnet placement was appropriate to disable the device.The patient underwent surgery where the generator was replaced.The explanted device has not been received by the manufacturer to date.No additional relevant information has been received to date.

Manufacturer Narrative

The initial report inadvertently did not include information that the device had been received by the manufacturer.¿no, 02¿ the initial report inadvertently stated the device had not been received to the manufacturer.However the device had been received and was pending analysis.(b)(4).The initial report inadvertently did not include information that the device had been received to the manufacturer and was pending analysis.(b)(4).

Event Description

The device was received by the manufacturer and the device underwent product analysis has been completed.The internal data of the generator was reviewed and it indicated that the generator had 172 successful magnet swipes since the manufacture date, including 15 magnet mode activations that occurred around the time that it was reported that the magnet did not inhibit vns stimulation.During functional analysis magnet activations were performed normally.Product analysis found that the device operated within specifications.

Manufacturer Narrative

Date received by manufacturer, corrected data: follow up report # 1 had the wrong date for the information received by the manufacturer.The correct date should have been 03/16/2017.

• Brand Name: PULSE GEN MODEL 106
• 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: 6381018
• MDR Text Key: 69164426
• Report Number: 1644487-2017-03333
• 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,consum
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 05/04/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2018
• Device Model Number: 106
• Device Lot Number: 203851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 17 YR