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

Model Number 106

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

Patient Problems Arrhythmia (1721); Chest Pain (1776); Neck Pain (2433)

Event Date 03/26/2019

Event Type  Injury  

Event Description

It was reported that the patient experienced sharp pains in their chest and neck with stimulation which began after a face forward fall.It was additionally reported by the representative that the patient experienced heart rate issues.Internal data of the patient's generator was reviewed and there was no evidence of any malfunction or anomalies with the generator.No further relevant intervention has been received to date.

Event Description

It was reported that the patient's previously reported heart rate issue was not related to the vns.The patient's heart rate variation caused the auto-stimulation feature to go off more frequently, which resulted in the patient's discomfort.The auto-stimulation settings were adjusted and the discomfort resolved.No further relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• 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: 8597935
• MDR Text Key: 144663967
• Report Number: 1644487-2019-00890
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• 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: 06/05/2019

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: 12/20/2018
• Device Model Number: 106
• Device Lot Number: 5162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/17/2019
• Initial Date FDA Received: 05/09/2019
• Supplement Dates Manufacturer Received: 05/16/2019
• Supplement Dates FDA Received: 06/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/19/2017
• 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): Other
• Patient Age: 38 YR