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 Bronchitis (1752); Paralysis (1997)

Event Date 11/19/2023

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 livanovas 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 is experiencing vocal cord paralysis one week after operation.No other relevant information has been received to date.

Event Description

Additional information was received noting that the patient experienced vocal cord paralysis that is probably related to implant procedure is and recovering/resolving.More information was received noting that the patient is also experiencing bronchitis which is assessed to be probably related to implant procedure.Patient was noted to be hospitalized and added medication was done as intervention no other relevant information has been received to date.

Manufacturer Narrative

B3.Date of event; corrected data; initial mdr inadvertently reported incorrect date.B5.Describe event or problem; corrected data; initial mdr inadvertently omitted known information regarding the report of vocal cord paralysis.

Event Description

It was later reported that the bronchitis and vocal cord paralysis have recovered/resolved.

Event Description

During file review it was noted that supplemental aware date on supplemental 01 report should have been (b)(6)2024.

Manufacturer Narrative

B5.Describe event or problem; corrected data; supplemental 01 inadvertently provided incorrect aware date in g3.Date received by manufacturer (mo/day/yr).

• 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: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 18345480
• MDR Text Key: 330727606
• Report Number: 1644487-2023-01802
• Device Sequence Number: 1
• Product Code: MUZ
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2024

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: Health Professional
• Device Model Number: 304-20
• Device Lot Number: 206054
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/18/2023
• Supplement Dates Manufacturer Received: 12/18/2023; 03/06/2024; 04/23/2024
• Supplement Dates FDA Received: 02/02/2024; 03/29/2024; 04/23/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2023
• 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; Disability
• Patient Age: 60 YR
• Patient Sex: Female