MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

Model Number 303-20

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

Patient Problem Paralysis (1997)

Event Date 04/05/2024

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 patient was diagnosed with vocal cord paralysis during stimulation, noting that the event would resolve with stimulation off.This occurred following a recent implant once titrated to 0.5ma.No other relevant information has been received to date.

Manufacturer Narrative

D6a.If implanted, give date (mo/day/yr); corrected data; initial report contained incorrect implant date.H3.Device evaluated by mfr?; code 81, device evaluation and return of the device is not necessary.It will not add value to the investigation as the root cause is known.

Event Description

The corrected implant date of the vns system was received.It was also reported that patient had lead revision surgery as the physician had assessed the cause of the vocal cord paralysis to be due to mispositioning of the lead electrode on the vagus nerve.Following the revision surgery the patient continued to show dysphonia symptoms without stimulation and was evaluated by surgeon who concluded that the patient has a left recurrent abduction paralysis with the onset of amyotrophy of the left vocal muscle.Patient has been referred for speech therapy and the vns therapy will be resumed during the rehabilitation process.Device evaluation is not necessary.It will add no value to the investigation as the root cause is known.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303
• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 19212974
• MDR Text Key: 341386170
• Report Number: 1644487-2024-00496
• Device Sequence Number: 1
• Product Code: LYJ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2024

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: 303-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 04/05/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/01/2022
• 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): Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Male