MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 302

Model Number 302-20

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

Patient Problems Pocket Erosion (2013); Skin Infection (4544)

Event Date 12/21/2023

Event Type  Injury  

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.H3.Device evaluated by mfr? code 81 - device evaluation is not necessary because the reported event has been determined as not related to the functionality or delivery of therapy of the device.

Event Description

The patient's leads were found to have eroded through their skin and they were scheduled to undergo explant surgery.It was later reported that the patient underwent explant surgery due to being a picker and having an infection.Additional information received noting that the cause of the lead extrusion and infection was due to patient manipulation.Device history record review for the lead was performed.The lead was confirmed to have been sterilized prior to distribution into the field.The device passed all specifications.

• Brand Name: LEAD MODEL 302
• Type of Device: LEAD
• Manufacturer (Section D): CYBERONICS - HOUSTON; 100 cyberonics blvd; houston TX 77058
• Manufacturer (Section G): CYBERONICS - HOUSTON; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18502392
• MDR Text Key: 332769085
• Report Number: 1644487-2024-00038
• 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
• Report Date: 01/12/2024

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/04/2005
• Device Model Number: 302-20
• Device Lot Number: 009493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/05/2003
• 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: 59 YR
• Patient Sex: Male