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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problems Apnea (1720); Convulsion, Clonic (2222); Syncope/Fainting (4411)

Event Date 03/07/2023

Event Type  malfunction  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.Health effect - clinical code :e1719.

Event Description

It was reported that high lead impedance and low output current was seen upon patient interrogation.The patient had an "episode" last week associated with a chest infection.He did not present with his usual seizure type and with a lack of consciousness.The patient was unconscious for some time and was put down to vasovagal syncope.They are now on antibiotics, but their provider is concerned that the syncope and high lead impedance may be connected.The patient has been referred for a battery replacement and x-rays.The patient was later hospitalized for more a second episode of seizure, unconsciousness, and stopped breathing.During this hospitalization, it was reported that there was a bent/ kinked or broken vns lead.Official confirmation of this has not been provided.The patient had x-rays performed, and a lead break was not visible in the image.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

It was later reported that the chest infection was related to external factors as the patient has multi morbidity and is prone to infections.The new seizure type was also related to external factors since the patient has lennox-gastaut syndrome with multiple seizure types.The syncope was thought to be related to the chest infection which is unrelated to vns.The patient¿s pallor has previously been related to his seizure semiology.The physician was unable to comment on the patient¿s low blood pressure, muscle weakness, and apnea.The referral for the battery replacement was only made for the device-related issues of low battery, high impedance, and low output current.

Event Description

Information was later received reporting that the patient had a full revision due to battery depletion and high impedance.Impedance was within normal limits with the new devices.The suspect device has not been received by the manufacturer to date.

Event Description

It was later reported that the lead was discarded and is therefore not available for return to the manufacturer.

• 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 16703726
• MDR Text Key: 312943397
• Report Number: 1644487-2023-00419
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/15/2023

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: 01/18/2020
• Device Model Number: 304-20
• Device Lot Number: 300387
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/07/2023
• Supplement Dates Manufacturer Received: 04/11/2023; 07/26/2023; 08/31/2023
• Supplement Dates FDA Received: 05/05/2023; 08/17/2023; 09/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• 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): Hospitalization; Life Threatening
• Patient Age: 37 YR
• Patient Sex: Male