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 Unspecified Infection (1930); Nausea (1970); Septic Shock (2068); Vomiting (2144); Tissue Breakdown (2681)

Event Date 07/30/2020

Event Type  Injury  

Manufacturer Narrative

Device evaluation is not necessary as the infection is not related to the functionality or delivery of therapy of the device.

Event Description

The patient was incarcerated and attempted to use an unidentified object to explant the vns device, this led to the infection at the neck incision site.It was noted that 3-4 inches of the lead was extruding from the neck.No additional information has been received to date.

Event Description

The patient's generator and leads were removed.

Manufacturer Narrative

Section b5.Describe event or problem: corrected data; initial mdr inadvertently did not state that the patient's lead and generator were removed.

Event Description

Further information was received indicating the patient had attempted to cut his throat with a razor blade and hit the vns lead.Shortly after, the patient began developing fevers up to 104 degrees and complained of nausea and vomiting.Oral antibiotics were administered for several weeks, however, the patient displayed worsening symptoms of sepsis and was hospitalized.In vns explant surgery, purulent material was noted superficially and deep within the neck.The surgeon completely removed the lead and generator and irrigated the chest and neck incision with antibiotics.Broad-spectrum antibiotics were used and surgical cultures showed mssa infection.

Event Description

The patient cut his neck in the vicinity of the transected lead.

• Brand Name: LEAD MODEL 304
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10408024
• MDR Text Key: 202942692
• Report Number: 1644487-2020-01069
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/20/2021
• Device Model Number: 304-20
• Device Lot Number: 204097
• Was Device Available for Evaluation?: No
• Event Location: Other
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR