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

Model Number 304-20

Device Problems Corroded (1131); High impedance (1291); Appropriate Term/Code Not Available (3191)

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

Event Date 11/17/2017

Event Type  malfunction  

Event Description

It was reported that high impedance was seen on the patient's device.The lead was replaced but the generator was not replaced.The explanted lead has not been received to date.

Event Description

The explanted lead was received.Analysis is underway but has not been completed.

Event Description

Abraded openings were noted on the outer and the inner silicone tubing of the returned lead portions.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing.No obvious point of entrance was noted other than the identified tubing openings and the end of the returned lead portion.The reported fracture of lead was verified.Scanning electron microscopy images of the positive coil show that pitting or electro-etching conditions have occurred at the break location.The positive coil shows what appears to be wear (smoothed surfaces) at the mate end in the vicinity of the break location.Also, the appearance of the positive coil mate end suggests a stress-induced fracture occurred in at least one strand of the quadfilar coil.Due to metal dissolution and or mechanical distortions (smoothed surfaces) the fracture mechanism of other strands cannot be ascertained.Since the electrode array portion was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Other than the above mentioned observations and typical wear and explant related observations, no other anomalies were identified in the returned lead portions.

Event Description

Additional information was received that the high impedance was first observed.The explanted lead was reported to be eroded or corroded into the jugular vein.No additional relevant information was received.

Event Description

No known interventions were taken specifically for the corrosion.

Event Description

It was later reported that the patients generator was replaced prophylactically.

• 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: 7143722
• MDR Text Key: 95792974
• Report Number: 1644487-2017-05076
• Device Sequence Number: 1
• Product Code: LYJ
• 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: Health Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/25/2015
• Device Model Number: 304-20
• Device Lot Number: 201780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2011
• 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: 13 YR
• Patient Sex: Male