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 Problem Nerve Damage (1979)

Event Date 02/24/2022

Event Type  Injury  

Event Description

It was reported that the clinical study patient has nerve injury which is probably related to implant procedure.The event was noted to be mild.No further relevant information has been received to date.

Event Description

It was reported that the patient has voice alteration that is unlikely related to implant procedure and possibly related to stimulation/device.The event is mild.It was not indicated to be related to the nerve injury but is being reported just in case.No further relevant information has been received to date.

Event Description

It was reported that the patient has hypoesthesia in the neck associated with the nerve injury.No further relevant information has been received to date.

Event Description

Additional information received noting that the reported voice alteration (hoarseness) is unlikely related to the implant procedure and stimulation but possibly related to the device.The outcome of the event was noted to be 'recovered/resolved'.

Manufacturer Narrative

Supplemental #4 failed due to a ¿duplicate report¿, therefore this supplemental report is a duplicate of supplemental #4 report to ensure the information is successfully submitted to the fda.A ¿passed¿ acknowledgement was not received from the fda for supplemental #4 due to the esg outage that occurred between 01/27/2023 ¿ 02/01/2023.¿.

Event Description

Additional information received in regards to the reported 'hypoesthesia of side of neck', noting that the event is now possibly related to stimulation/device.

• 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: 14104145
• MDR Text Key: 289203900
• Report Number: 1644487-2022-00434
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/31/2023

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: Lay User/Patient
• Device Model Number: 304-20
• Device Lot Number: 205759
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/21/2022; 05/04/2022; 06/13/2022; 01/05/2023; 01/05/2023; 03/08/2023
• Supplement Dates FDA Received: 05/13/2022; 05/26/2022; 07/08/2022; 01/30/2023; 02/02/2023; 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2021
• 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
• Patient Age: 47 YR
• Patient Sex: Male