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

Model Number 302-20

Device Problems Fracture (1260); High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/16/2023

Event Type  malfunction  

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 livanovas 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

It was reported that during a follow up, the patient was seen with high impedance.The patient was sent for x-rays.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

Event Description

Additional information was received from the physician, reporting that the believed cause of the high impedance is still unknown, however there was not any reported trauma/manipulation to the site.The patient has been referred to the surgeon for revision and the x-rays that were taken were received and reviewed.The generator placement was located at a normal placement.Based on the x-ray images provided, the feedthrough wires and complete pin insertion were unable to assessed due the image quality and angle of the image.Most of the lead could be visualized, and a strain relief loop could be seen, one around the generator and another near the placement of the electrodes.The tie downs were present and appeared to be placed per labeling.A portion of the lead was visualized to be behind the generator.A portion of the lead was assessed for fracture and discontinuities on the visible portions of the lead and just under the placement of electrodes a lead fracture is visible.In the notated version of the x-rays the fractured has been highlighted.Based on the x-rays received, the cause of the high impedance is due to the gross fracture just beyond the stress relief bend.No known relevant surgical intervention has occurred to date.No other 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: dana sprague ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 17720680
• MDR Text Key: 323091497
• Report Number: 1644487-2023-01301
• Device Sequence Number: 1
• Product Code: MUZ
• 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
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/05/2011
• Device Model Number: 302-20
• Device Lot Number: 200731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2008
• 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: 56 YR
• Patient Sex: Male