MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103; GENERATOR

Model Number 103

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

Patient Problem Chest Pain (1776)

Event Date 12/27/2016

Event Type  Injury  

Event Description

It was reported to a company representative that a vns patient was experiencing painful stimulation with the device.Clinic notes were received from a visit on (b)(6) 2017.The notes described that the patient was experiencing irritation with vagus nerve stimulation cycles.The battery was reported to be at full capacity and there was no ¿weak¿ impedance.During the clinic visit on (b)(6) 2017, it was decided to tape the magnet in place to stop stimulation and assess if the painful stimulation resolves.The patient also wanted to continue referral for surgery in the meantime.The provider stated that they had wrapped the magnet in place themselves during the visit.Follow-up from the physician provided that the painful stimulation did not resolve after the magnet had been taped in place.The patient was scheduled for surgical consult, but no known surgery has occurred to-date.Additional relevant information has not been received to-date.

Event Description

It was reported that the patient's generator and leads were explanted.Product return is not expected to date.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 103
• Type of Device: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 6376264
• MDR Text Key: 69011822
• Report Number: 1644487-2017-03309
• 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: 01/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• 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: 3287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2012
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 24 YR