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 Problems Muscle Spasm(s) (1966); Neck Pain (2433)

Event Date 06/01/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The patient began experiencing painful stimulation in her left neck and throat as well as voice alteration and muscle spasms.The patient noted that the tie-down used to secure the lead was more visible in her neck than it was previously.X-rays were performed and reviewed by the medical professional and showed no abnormalities.The patient's output current was decreased in response to these issues.Despite the normal x-rays and diagnostics, the doctor believes there is an issue with the lead and the patient has been referred for full revision surgery of the vns system.No known surgical intervention has occurred to date.No additional information has been received to date.

Event Description

The patient's generator was explanted and replaced.The lead was not replaced.The explanted device has not been received by the manufacturer to date.

Event Description

The explanted generator was received for analysis.The generator was confirmed to be able to provide the programmed output current without issue.The septum was not cored, thus eliminating the possibility of a potential unintended electrical current path through body fluids.A comprehensive automated electrical evaluation showed that the device performed according to functional specifications.

• Brand Name: LEAD MODEL 303
• Type of Device: LEAD
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 10407016
• MDR Text Key: 202880101
• Report Number: 1644487-2020-01059
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/30/2020

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 Expiration Date: 09/08/2019
• Device Model Number: 303-20
• Device Lot Number: 203507
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/20/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 09/14/2020; 10/06/2020
• Supplement Dates FDA Received: 10/09/2020; 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 52 YR