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 Problem Pain (1994)

Event Date 09/29/2014

Event Type  Injury  

Event Description

A patient began experiencing intermittent pain at the neck site in the neck in 2014.The patient has since reported in 2017 pain in her neck and in her chest and armpit area too, and wants the battery explanted.Clinic notes for surgical referral provided that the patient is requesting vns to be removed as she is having pain at the site of vns implantation up into her neck.The device has been off since 2015 she states she is unable to move her left arm above her chin level.The notes provided they were unable to palpate chest wall to check for vns placement due to pain as the patient moves away and refuses further examination.Additional relevant information has not been received to-date.No known surgery has occurred to-date.

Event Description

The generator was later explanted, but has not been received by the manufacturer to-date.

Event Description

The explanted device was reported to have been discarded by the hospital.

Event Description

It was later reported by the patient that their device was explanted due to battery depletion, and since she did not think it was working.The patient¿s seizures were under control and were stress induced.The patient's physician clarified that the patient's device was explanted in 2017 since the patient no longer desired vns.Only the generator was explanted, not the leads.

• 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: 6695815
• MDR Text Key: 79350420
• Report Number: 1644487-2017-04119
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2014
• Device Model Number: 103
• Device Lot Number: 202066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2012
• 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
• Treatment: NA.
• Patient Age: 20 YR
• Patient Sex: Female