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 Pocket Erosion (2013); Post Operative Wound Infection (2446)

Event Date 05/28/2021

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as reported event(s) are not related to the functionality or delivery of therapy of the device.

Event Description

Clinical patient was experiencing a rash, which progressed to infection and extruding lead at the neck incision.Patient was noted to have been admitted and the device was set to be removed.The infection was reported to be due to the implant surgery.The infection was reported to have resolved.Product return and device evaluation is not necessary as the reported event is not related to the functionality or delivery of therapy of the device.No known surgery has occurred to date.No additional relevant information has been received.

Event Description

It was reported the patient's devices had been explanted.No additional relevant information has been received to date.

Event Description

It was reported that the infection was seen to occur at both the generator and lead site.No additional or relevant information has been received to date.

• 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: 12284862
• MDR Text Key: 265345824
• Report Number: 1644487-2021-01068
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2022

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 Model Number: 304-20
• Device Lot Number: 6316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 08/05/2021
• Supplement Dates Manufacturer Received: 08/25/2021; 06/10/2022
• Supplement Dates FDA Received: 09/17/2021; 06/30/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/02/2021
• 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; Required Intervention; Other
• Patient Age: 33 YR
• Patient Sex: Female