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 Chest Pain (1776); Dyspnea (1816); Pain (1994)

Event Date 01/01/2018

Event Type  Injury  

Event Description

It was reported that the patient was experiencing painful stimulation and pressure in the chest, shortness of breath, and left arm pain.The diagnostics were found to be within normal limits.It stated that the patient was experiencing cardiac pain symptoms, but the physician did not think they were related to the vns.The vns parameters were programmed at various settings in an attempt to replicate the pain described by the patient.The patient was referred for a complete cardiac checkup with a holter monitor in order to rule out any relationship between his chest pain and vns.The patient requested removal as he had found the generator uncomfortable and the area was sore due to being bumped regularly when playing with his children.The patient underwent vns explantation surgery.The explanted products have not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

Follow up with the surgeon's office revealed that the surgical intervention was for the patient's comfort.

Event Description

The explanted generator and lead were received by the manufacturer.Analysis on the lead was approved.Note that since the lead¿s electrodes were not returned for analysis, an evaluation and resulting commentary could not be made on that portion of the lead.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portions.Analysis on the generator has not been approved to date.

Event Description

Generator product analysis was completed.The reported pain, painful stimulation, and dyspnea could not be evaluated in the product analysis, or pa, lab.However, proper functionality of the generator was verified in the pa lab.The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids, which addresses the allegations of pain and painful stimulation.The generator was placed in a simulated body temperature environment and the output signal was monitored for more than 24 hours.No signs of variation in the signal were observed and diagnostics were as expected for the programmed parameters.The generator performed according to functional specifications.There were no performance of other adverse conditions found with the generator.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7544133
• MDR Text Key: 109233234
• Report Number: 1644487-2018-00871
• 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,Followup,Followup
• Report Date: 07/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/23/2019
• Device Model Number: 106
• Device Lot Number: 5381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2017
• 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): Required Intervention
• Patient Age: 29 YR