MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 7304

Model Number 7304-20

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

Patient Problems Pocket Erosion (2013); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/08/2022

Event Type  Injury  

Event Description

It was reported that the electrodes extruded through the skin at the neck site and the electrode had to be inserted back in the correct position.Stimulation was still functional.The electrode then extruded again a couple of months later and the patient was hospitalized and had wound revision and electrode reinsertion.The clinical study site noted the events to be related to vns stimulation.No further relevant information has been received to date.

Manufacturer Narrative

F10: proposed second level coding - protrusion to capture incidents of a device being visible under the skin.

Event Description

Per the physician it was reported that the lead had never broken the skin, but is rather protruding underneath the skin.The physician believed the cause to be due to "the strain on the neck and the sutures allowed in the loop area" no additional or relevant information has been received to date.

Event Description

It was reported that the cause of the protrusion was related to patient physiology.The lead (specifically strain relief loop) had protruded over the sternocleidomastoid muscle due to weak connective tissue.There was no failure of the device seen.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 7304
• 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: 14519598
• MDR Text Key: 292799811
• Report Number: 1644487-2022-00615
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Foreign,Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2022

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: 7304-20
• Device Lot Number: 204479
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 05/03/2022
• Initial Date FDA Received: 05/26/2022
• Supplement Dates Manufacturer Received: 07/01/2022; 08/24/2022
• Supplement Dates FDA Received: 07/25/2022; 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2018
• 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
• Patient Sex: Female