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

Model Number 304-20

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/30/2019

Event Type  malfunction  

Event Description

It was reported that high impedance was seen on a patient's device.It was also reported that all of the patient's output currents were programmed off.Additional information was received that per the neurosurgeon, it was assumed that it was in a dance class that she felt something had happened on the generator.Photos of the patient's ap and lateral neck and chest x-rays were also received and reviewed and revealed that the cause of the high impedance is likely lead fracture, as it does appear that the leads are coiled which can lead to a lead discontinuity as well as a possibly discontinuity visualized.Device history records were reviewed on and the device passed all functional specifications and quality tests and were sterilized prior to distribution.Though surgery is likely, no surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

Information was received that there was no high impedance seen with the old generator and new lead.It was stated the generator was changed first, and then after changing the generator and checking the generator they saw high impedance.It was observed at this time that the lead was damaged and there it was replaced.A generator diagnostic was not run with the new generator.The lead and generator have been discarded.No additional relevant information has been received to date.

Event Description

The patient had a full explant of the vns system.The explanted devices have not 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8633801
• MDR Text Key: 145858975
• Report Number: 1644487-2019-00991
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 0542502575013
• UDI-Public: 010542502575013
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/18/2020
• Device Model Number: 304-20
• Device Lot Number: 4935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 08/02/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2016
• 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 Age: 45 YR