MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

Model Number 304-30

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

Patient Problem Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/20/2023

Event Type  Injury  

Event Description

Patient is scheduled for exploratory surgery of the neck and possible revision of the lead due to spasms the patient experiences with device stimulation.The patient's physician notes that the patient has met with an ent, physical medicine & rehab specialist as well as reduced the patient's settings and no one can pinpoint what is causing the spasms.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

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

Lead revision was performed as the surgeon thought that a 2mm lead would be better for the patient.No adverse conditions on the lead were found at explant.Explanted lead has not been received to date.No other relevant information has been received to date.

Event Description

The explanted lead was returned and received.Product analysis has not yet been performed on the device.No other relevant information has been received to date.

Manufacturer Narrative

Supplemental report 1: adverse event problem: health effect - impact code: f1905.Adverse event problem codes: type of investigation: b17.Supplemental report 2: device available for evaluation?: yes.If yes, returned to manufacturer on (mo/day/yr): 10/24/2023.

Event Description

Product analysis was completed on the returned lead.Continuity checks of the returned lead portion were performed during the functional analysis, and no discontinuities were identified.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.Other than typical wear and explant related observations, no anomalies were identified in the returned lead portion.No other relevant information has been received to date.

• 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: 17321814
• MDR Text Key: 319021715
• Report Number: 1644487-2023-00908
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750153
• UDI-Public: 05425025750153
• 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,Followup,Followup
• Report Date: 01/02/2024

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: 304-30
• Device Lot Number: 205515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 07/24/2023; 10/24/2023; 12/12/2023; 12/12/2023
• Supplement Dates FDA Received: 08/18/2023; 11/14/2023; 12/12/2023; 01/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2021
• 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: 19 YR
• Patient Sex: Female