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

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

Patient Problems Local Reaction (2035); Neck Pain (2433); Fibrosis (3167); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/21/2021

Event Type  Injury  

Event Description

The patient reported experiencing pain and a "lump" at the electrode site.The patient was referred for x-rays, and was referred to an ent surgeon for evaluation.Update was received indicating that the patient underwent exploratory surgery and a "clip" was removed (likely a tie down on the lead).The vns was noted to still be functioning, and the generator/lead were not explanted at this time.No additional relevant information has been received to date.

Manufacturer Narrative

F10, health effect clinical code, corrected data: initial report should have used code e2402 for the reported protrusion.Proposed second level coding - protrusion to capture incidents of a device being visible under the skin.

Event Description

Further information was received from the physician that the patient had a ct scan completed as part of diagnostics after the exploratory surgery.Physician reported that fibrosis was the possible cause of the lump at the electrode site.Patient surgery was noted to be for comfort.Surgical notes were provided for date of surgery on (b)(6) 2021.It was noted that patient presented with left neck pain with vagal nerve stimulator and that the retaining clip was removed.Patient noted to have significant pain at lead neck site and that a ct scan did not show any evidence of infection.Surgeon noted that clip seemed to be the area that was tender when patient was examined.No obvious infection was observed, and clip was sent for culture and sensitivity.Surgeon noted that no other clips were observed, and he did not want to proceed with further exploration therefore the patient was closed.Vns was noted to still be working after surgery and patient reported to tolerate procedure well.No additional relevant information has been received to date.

• Brand Name: LEAD MODEL UNKNOWN
• 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: 12189854
• MDR Text Key: 262252208
• Report Number: 1644487-2021-00972
• 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,Followup,Followup
• Report Date: 07/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Sex: Female