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

Model Number 304-20

Device Problems Fracture (1260); Device Contamination with Body Fluid (2317); Material Twisted/Bent (2981)

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

Event Date 11/18/2020

Event Type  malfunction  

Event Description

The patient underwent full revision surgery due to high impedance.The suspect device has not been received by the manufacturer to date.No additional relevant information has been received to date.

Event Description

Device has been received and is undergoing product analysis.No other relevant information has been received to date.

Event Description

Product analysis was completed for the returned device.After review of received data from explanted devices, it was found that high impedance was seen at a much earlier date.Product analysis of the lead was completed.Continuity checks of the returned lead portion were performed during the functional analysis, and no discontinuities were identified.The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.Two sets of set setscrew marks were observed on the connector pin.The marks provide evidence of a proper mechanical contact between conductive surfaces of both the generator and connector pin, thereby ensuring a good electrical connection to the lead at one point in time.Abrasions were observed in various areas, likely due to wear.The lead assembly has dried remnants of what appear to have once been body fluids inside the inner and the outer silicone tubing, in some areas.No obvious point of entrance was noted other than the identified cut tube opening and the cut end of the returned lead portion.Note that since a portion of the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Product analysis of the generator was completed.A comprehensive automated pcba electrical evaluation and a battery life calculation were performed.Other than the ifi ¿vboost¿ compliance voltage event, no anomalies were seen, and the device performed according to functional specifications.No other 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
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics blvd; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 11392199
• MDR Text Key: 233990921
• Report Number: 1644487-2021-00284
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• 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,Followup
• Report Date: 01/10/2024

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: 02/09/2020
• Device Model Number: 304-20
• Device Lot Number: 4735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 03/01/2021
• Supplement Dates Manufacturer Received: 10/20/2023; 12/19/2023
• Supplement Dates FDA Received: 11/13/2023; 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2016
• 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: 27 YR
• Patient Sex: Male