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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 10/17/2019

Event Type  malfunction  

Event Description

It was reported that the patient's lead was replaced due to lead discontinuity and generator replaced prophylactically.The patient's generator and lead have been received into analysis however analysis has not been completed to date.No additional relevant information has been received to date.

Event Description

Generator analysis was completed and the high impedance was not replicated on the generator as various electrical loads were attached to the generator and diagnostic tests were normal.An automated evaluation showed that the device functioned as expected.Lead analysis was completed and braded openings were noted in the outer silicone tubing.The reported of lead fracture were verified.A break was identified in the negative coil.Scanning electromagnetic images of the negative coil show putting or electro-etching conditions had occurred in the break location.The coil appearance also suggested a stress-induced fracture in at least one strand of the quadfilar coil.Note that since the furthest electrode to the bifurcation 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.No additional relevant information has 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
• MDR Report Key: 11096376
• MDR Text Key: 225839454
• Report Number: 1644487-2020-01755
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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
• Type of Report: Initial,Followup
• Report Date: 02/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2020
• Device Model Number: 304-20
• Device Lot Number: 4923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Event Location: Other
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/30/2020
• Supplement Dates Manufacturer Received: 01/12/2021
• Supplement Dates FDA Received: 02/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR