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

Model Number 304-20

Device Problem High impedance (1291)

Patient Problems Choking (2464); Cough (4457)

Event Date 09/13/2021

Event Type  malfunction  

Event Description

The patient was experiencing a choking sensation with stimulation for a week and then the device was checked and showed high impedance.The device was turned off, which resolved the choking issue.It was noted that the patient did not experience any trauma.X-rays were reviewed.Based on the images provided, the feed through wires were intact, however it could not be assessed if the lead pin is fully inserted in the generator due to the angle of the image.The lead was visualized in the chest and neck.The presence of strain relief could not be assessed due to the quality and scope of the image.A portion of the lead was visualized to be routed behind the generator.The lead was assessed for fracture and discontinuities on the visible portions of the lead however none were noted.Based on the x-rays received, the cause of the high impedance cannot be confirmed.Note that the presence of a micro-fracture and/or a lead discontinuity could not be ruled out in the portion of the lead that is not visible in the provided images.The device history records of the lead were reviewed.The lead passed final quality and functional specifications prior to release.No further relevant information has been received to date.No known relevant surgical intervention has occurred to date.

Event Description

The patient's husband reported that the patient was coughing out of control as if someone was choking her thus they took the patient to the doctor and an error was seen (high impedance).It was noted that this situation has caused physical pain and emotional pain.No further relevant information has been received to date.No known relevant surgical intervention has occurred 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 12639392
• MDR Text Key: 276635994
• Report Number: 1644487-2021-01419
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Consumer,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 12/03/2021

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/24/2023
• Device Model Number: 304-20
• Device Lot Number: 6190
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 09/20/2021
• Initial Date FDA Received: 10/15/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 12/03/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2019
• 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): Required Intervention
• Patient Age: 31 YR
• Patient Sex: Female