MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 104; GENERATOR

Model Number 104

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

Patient Problem Neck Pain (2433)

Event Date 10/01/2015

Event Type  Injury  

Event Description

It was reported that the patient experiences a sharp pain in her left neck during stimulation every 2 months.Usually, the severity of the pain diminished over the course of the day.However, more recently, the pain was not easing over the course of the day.The doctor decreased the frequency, and the pain also decreased.In (b)(6) 2015 the patient had severe pain associated with her vns, and the pain resolved with a decrease in pulse width.Because of the painful stimulation, the patient was referred to see a surgeon for replacement.The patient reported that the vns is causing her excruciating pain, and she wants to claw it out of her neck.When this happens, it occurs just 3 or 4 times, or an entire day.No known surgical interventions for vns have occurred to date.No additional relevant information has been received to date.

Event Description

The patient underwent surgery and had their generator replaced.The explanted generator has been received by the manufacturer.Analysis is underway but has not been completed to date.

Event Description

The generator underwent product analysis and exhibited proper functionality in its ability to provide appropriate programmed output currents.The device output signal was monitored for more than 24 hours where results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.In addition, a comprehensive automated electrical evaluation showed that the pulse generator performed according to functional specifications.There were no additional performance or any other type of adverse condition found with the pulse generator.

• Brand Name: PULSE GEN MODEL 104
• 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: 6821496
• MDR Text Key: 83675576
• Report Number: 1644487-2017-04370
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/08/2017

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: 12/31/2014
• Device Model Number: 104
• Device Lot Number: 202372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/31/2017
• Initial Date FDA Received: 08/25/2017
• Supplement Dates Manufacturer Received: 09/11/2017; 10/17/2017
• Supplement Dates FDA Received: 10/04/2017; 11/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/09/2013
• 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: 49 YR