MAUDE Adverse Event Report: LIVANOVA USA, INC. BIPOL LEAD MODEL 300

Model Number 300-20

Device Problem High impedance (1291)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fibrosis (3167); No Code Available (3191)

Event Date 06/21/2001

Event Type  malfunction  

Event Description

It was reported that a patient's device was disabled about 8 years ago due to shortness of breath.The patient was seen by a new physician on (b)(6) 2016, and high impedance was identified during normal mode and system diagnostics.The patient was referred for full revision surgery.Programming history was available from the date of implant, (b)(6) 2001, and a system diagnostic test performed during implant showed high impedance.No further diagnostic results were available, so it is unknown if the high impedance resolved during surgery or not.Clinic notes were received on 02/29/2016.The patient felt that the vns took his breath away, especially when he used the magnet.The patient then had his vns turned off.The physician discussed turning the vns back on, and the patient agreed.The notes also mention that the patient was positive for chest pains, shortness of breath, and wheezing on (b)(6) 2016.This indicates that the patient still had shortness of breath after the vns was disabled.However, the shortness of breath may have been worsened by the magnet stimulation.Also, it is unknown if the shortness of breath was related to the high impedance or not.No further relevant information has been received to date.

Event Description

Clinic notes were received on 04/01/2016 from the surgeon's office.The physician stated that the patient has a broken lead, which needs to be replaced during surgery.The patient had vns initially implanted in the 1990's, and vns stopped his seizures.However, he had it deactivated because it took his breath away and made him feel like he could not breathe.The patient is wanting to use vns again.The notes also mention that the device was recently tested, and it was not working.The patient uses an inhaler for breathing issues, which supports that the patient has breathing issues without vns stimulation as well and were not related to the high impedance.Attempts for further information were unsuccessful to date.No surgical intervention has occurred to date.

Event Description

It was reported that patient underwent lead and generator replacement surgery.The explanted lead and generator were discarded following the surgery.Therefore, product analysis cannot be completed.

Event Description

Clinic notes were received from the surgeon's office indicating that as well as the shortness of breath and painful stimulation that led to the vns disablement and full revision, the patient also experienced voice alterations.The surgeon's notes also indicated that during the full revision surgery, it was identified that both the electrodes and the generator were encased in scar tissue.Attempts have been made to obtain additional information regarding the voice alteration and the scar tissue.No additional relevant information has been received to date.

Event Description

Per the physician, the cause of the voice alterations was vns stimulation, and the cause of the fibrosis was due to implantation surgery.The physician indicated that the full revision that occurred was not completed or planned due to the voice alterations or fibrosis.No additional relevant information has been received to date.

• Brand Name: BIPOL LEAD MODEL 300
• Type of Device: LEAD
• 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: 5512641
• MDR Text Key: 41029903
• Report Number: 1644487-2016-00587
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2003
• Device Model Number: 300-20
• Device Lot Number: 2656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 12/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/27/2001
• 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: 52 YR