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 Ecchymosis (1818); Unspecified Infection (1930); Tissue Breakdown (2681); Fluid Discharge (2686)

Event Date 09/16/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary because the reported event has been determined as not related to vns therapy.

Event Description

It was reported that the patient had a hematoma over the neck electrode site which then opened and began oozing pus and fluid.The opening then became larger and the lead wires were noted be exposed on the neck.Information was received that the patient underwent wound revision surgery and the vns device was not explanted.An incision and debridement was conducted on the neck without removing the generator or lead.The site was reported to be cleaned out and closed.No other relevant information was been received to date.

Event Description

Information was received that the patient underwent generator explant surgery due to site infection.A review of device history records showed that both the lead and generator were sterilized prior to distribution.No other relevant information has been received to date.

Manufacturer Narrative

H3.Device evaluated by mfr?, code 81: device evaluation is not necessary as the infection and wound dehiscence is not related to the functionality or delivery of therapy of the device.

Event Description

Corrected information was reported in mfg report#: 1644487-2021-00102.It was reported in mfg report #: 1644487-2020-01362 follow up #01, that the patient underwent a generator explant due to an infection.Upon further evaluation, it was noted that a separate mfg report should be created as the report of infection was unrelated to the events reported in the initial report and the suspect product has now changed.This information has now been reported in mfg report#: 1644487-2021-00102.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10657726
• MDR Text Key: 210673257
• Report Number: 1644487-2020-01362
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/08/2019
• Device Model Number: 304-20
• Device Lot Number: 4655
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 01/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 15 YR