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

Model Number 304-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Implant Pain (4561)

Event Date 03/01/2020

Event Type  Injury  

Event Description

It was reported that the patient was unable to tolerate an mri due to lead heating and pain.The patient¿s physician noted that the patient experienced the pain due to the placement of the lead ¿ it was not in the required area to pursue an mri.The patient was referred for a battery replacement.The physician later clarified that a full system replacement was the intervention for battery depletion, lead heating, and pain.This intervention was both for patient comfort and to preclude serious injury.There was no indication that the lead had migrated or was implanted against guidance in manufacturer's labeling.The patient had a battery replacement due to battery depletion.No other relevant information has been received to date.

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.

Manufacturer Narrative

H6.Corrected investigation findings, initial report: inadvertently listed wrong coding instead of c0901.

Manufacturer Narrative

B4.Corrected date of this report, initial report: inadvertently left section blank g3.Corrected date received by manufacturer, initial report: inadvertently left section blank.

• 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: 16854139
• MDR Text Key: 314390527
• Report Number: 1644487-2023-00536
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2023

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2015
• Device Model Number: 304-20
• Device Lot Number: 201699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 04/07/2023; 06/01/2023
• Supplement Dates FDA Received: 05/08/2023; 06/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2011
• 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): Other
• Patient Age: 41 YR
• Patient Sex: Female