MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problem Fracture (1260)

Patient Problems Chest Pain (1776); Dyspnea (1816); Twitching (2172); Neck Pain (2433)

Event Date 06/04/2021

Event Type  malfunction  

Event Description

Patient reported chest and neck pain and was told to use their magnet to disable their device until they were seen in clinic.When the patient was seen, they presented with high impedance,and had x-rays performed but no obvious breaks were seen.The patient denies any falls or changes in seizures.The patient was referred for a full revision.Additional information was received which noted that the patient was involved in a motor vehicle accident rollover.No known surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information received indicating that the patient reported intense pain, inability to breath, and excessive muscle stimulation a week after having a car accident.The patient had their device disabled and noted that she felt relief but still had some muscle spasms.No other relevant information has been received to date.

Event Description

It was later reported that patient had a generator and lead replacement.Impedance was within normal limits after surgery.It was reported that the hospital discards the explanted devices so they are not available for return.

• Brand Name: LEAD MODEL 302
• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12091641
• MDR Text Key: 259145813
• Report Number: 1644487-2021-00891
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/19/2012
• Device Model Number: 302-20
• Device Lot Number: 2266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 10/05/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2009
• 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 Age: 40 YR
• Patient Sex: Female