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 Paralysis (1997); Paresis (1998)

Event Date 03/17/2023

Event Type  Injury  

Manufacturer Narrative

Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.

Event Description

It was reported that the patient experienced extreme hoarseness after implant.It is noting that the patient's voice has gotten better but is still not the same as compared to before surgery.The patient had their device turned on and all values were within normal limits and there were no complaints received from the patient when the device was activated.The patient was later seen by an ent who reported that the patient's vocal cords were not functioning properly from the vns surgery.The patient will undergo a mri scan and then a plan will be devised to treat the patient afterwards.It was confirmed that the issue is with the patient's left vocal cord.The device history records for the lead were reviewed.The lead passed final functional and quality specifications prior to release for distribution.No other relevant information has been received to date.

Manufacturer Narrative

D5 operator of device, corrected data: initial report inadvertently did not select health professional.

Event Description

The patient was referred for a revision.The patient then underwent exploratory surgery and it was determined that the left vocal cord is not completely paralyzed.They conducted nerve testing and the vagus nerve is not severed nor is the recurrent laryngeal nerve.The generator and lead were not replaced but a system diagnostics was performed and the lead impedance was within normal limits.The ent is planning to provide vocal cord injections to treat the patient.

Event Description

Additional information received noting that the patient was recently seen in clinic and their voice is now fully restored.

• 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: 17332641
• MDR Text Key: 319182098
• Report Number: 1644487-2023-00942
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/02/2023

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: Health Professional
• Device Model Number: 304-20
• Device Lot Number: 205953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/22/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 07/17/2023; 09/07/2023
• Supplement Dates FDA Received: 08/09/2023; 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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): Disability
• Patient Age: 52 YR
• Patient Sex: Male