MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

Model Number 302-20

Device Problems High impedance (1291); Low impedance (2285)

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

Event Date 10/09/2018

Event Type  malfunction  

Event Description

An implant card was received which noted that high/low lead impedance was observed during the patient's vns generator replacement due to battery depletion.Lead impedance was also marked to be normal on the implant card.Ap neck x-rays of the patient were previously reviewed.The connector pin appeared to be fully inserted inside the connector block, and feedthru wires appeared intact.There appeared to be a portion of the lead wire located behind the generator which was unable to be assessed.No obvious gross lead discontinuities or sharp angles were observed in the visible portion of the lead.Due to the image quality and angles, the lead and generator could not be completely assessed.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.No additional or relevant information has been received to date.

Event Description

Follow up was performed with the surgeon who performed the procedure and completed the implant card which noted the impedance issue.Information was received that the high/low impedance box was marked incorrectly and there was no issue with impedance.No additional or relevant information has been received to date.

• Brand Name: LEAD MODEL 302
• 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: 8432296
• MDR Text Key: 139195577
• Report Number: 1644487-2019-00536
• Device Sequence Number: 1
• Product Code: LYJ
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/16/2009
• Device Model Number: 302-20
• Device Lot Number: 200350
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 03/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2006
• 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: 38 YR