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

Model Number 304-20

Device Problems Fracture (1260); Mechanical Problem (1384)

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

Event Date 10/06/2019

Event Type  malfunction  

Event Description

It was reported that high impedance was detected on the patient's generator.The physician reported they believe it was 'likely a lead break.' no known relevant surgical intervention has occurred to date.No further relevant information has been received to date.

Event Description

The patient underwent a full replacement.The explanted devices have not been received for analysis to date.

Event Description

The explanted devices were returned for product analysis.Product analysis was performed on the explanted lead and generator.Visual analysis confirmed quadfilar coil appeared to be broken in two locations not related to explant of the device.Pitting was observed preventing the identification of the coil fracture type in the first location.In the second location, the coil was worn to the point of fracture with flat spots on the coil.Lead insulation was observed to be abraded due to wear.Based on the findings in the product analysis, there is evidence to suggest a discontinuity in the returned portions of the device.The electrode array section was not returned for analysis, and therefore an evaluation and resulting commentary cannot be made on that portion of the lead.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: 9532689
• MDR Text Key: 183503533
• Report Number: 1644487-2019-02528
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

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: 11/02/2018
• Device Model Number: 304-20
• Device Lot Number: 203159
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Event Location: Other
• Initial Date Manufacturer Received: 12/12/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 03/12/2020; 09/28/2020
• Supplement Dates FDA Received: 04/06/2020; 10/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 15 YR