MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-20

Device Problems High impedance (1291); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Convulsion, Clonic (2222); Neck Pain (2433); Choking (2464); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 11/01/2020

Event Type  malfunction  

Event Description

It was reported that the patient's leads were bothering her.She had x-rays and the ct neck showed that the leads terminate at the superficial aspect at the left carotid bifurcation.The treating nurse stated that the leads were definitely on the left carotid.Also the patient was experiencing recurring "shock-like" sensations.She also had been having difficulty eating and swallowing.She admitted that she choked on water.She also complained of muscle rigidity with intermittent spasms in the left lateral neck area.The patient's vns was disabled as a result.The patient continued to have pain afterwards.The patient was referred for revision surgery as it was suspected that the lead was not on the vagus nerve.The nurse indicated that the planned revision was both for comfort and to preclude a serious injury.No known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

Additional information was received indicating that the patient's vns showed high lead impedance.The patient was referred for revision surgery.

Event Description

Additional information received reporting that the patient is experiencing an increase in seizures and their device is currently off.

Event Description

Additional information received noting that the patient had their device turned back on at some point.

• Brand Name: LEAD MODEL 304
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12940441
• MDR Text Key: 284214648
• Report Number: 1644487-2021-01707
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/22/2024

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/19/2022
• Device Model Number: 304-20
• Device Lot Number: 204387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/06/2021
• Supplement Dates Manufacturer Received: 02/18/2022; 04/13/2022; 02/28/2023; 02/28/2024
• Supplement Dates FDA Received: 03/15/2022; 05/05/2022; 03/24/2023; 03/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2018
• 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: 37 YR
• Patient Sex: Female