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

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to a company representative that a patient¿s generator is migrating down to the armpit and the patient has complained that it¿s painful near the muscle around the armpit area when it migrates.The physician took x-rays and it showed that it was in a normal location when the x-ray was taken but the patient can feel it moving if she pushed it and it was reported that the patient could flip the generator if she tried, although it was reported that she hasn¿t flipped it.The patient later reported that she saw the surgeon and is planning surgery to replace the battery and lead, stating that the device has migrated underneath her armpit area and with her work she gets pain in the generator site with movement.The pain is constant but increases when the device goes off.The pain will radiate up to the neck area and further to the jaw at time of stimulation.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

Follow-up from the company representative provided that after the patient had been to see the surgeon, he had concluded the device has not migrated.

Event Description

Further follow-up with the physician¿s office 03/06/2017 provided the patient had been scheduled for surgery.It was decided to perform the surgery after seeing the surgeon again and they were able to palpate it and find that it was moving after doing so.Generator replacement surgery occurred on (b)(6) 2017.The explanted device has not been received by the manufacturer to-date.

Event Description

The explanted device was received by the manufacturer.Analysis is underway, but has not been completed to-date.

Event Description

Analysis was completed for the returned generator.The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids.The pulse generator was programmed to the as-received settings, and the output signal was monitored for more than 24 hours, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the output signal, and demonstrated that the device provided the expected level of output current.A comprehensive electrical evaluation showed that the pulse generator performed according to specifications.The battery measured 2.893 volts and was not in a depleted condition.The downloaded data revealed that 55.345% of the battery had been consumed.There were no performance or any other type of adverse conditions found with the pulse generator.

• 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: 6344391
• MDR Text Key: 67800773
• Report Number: 1644487-2017-03231
• 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
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/30/2015
• Device Model Number: 103
• Device Lot Number: 202581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2017
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 10/31/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2014
• 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: 28 YR