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

Model Number 302-20

Device Problems Corroded (1131); Fracture (1260)

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

Event Date 07/01/2019

Event Type  malfunction  

Event Description

It was reported that the patient was seen in clinic and found to have high impedance by their physician.Information was received from the physician that the patient's device was disabled due to high impedance.No surgical intervention has been reported to date.No additional relevant information has been received to date.

Event Description

The generator and lead were received for analysis with no explanation a lead fracture was identified in the analysis lab.It was determined through obituary search that the devices were explanted due to the patient's death which was unrelated to vns.A break was identified at the end of returned lead portion of the positive coil.The positive coil has pitting and wear (flat surfaces) in the vicinity of the break location.Due to mechanical distortion and/or metal dissolution the fracture mechanism cannot be ascertained.Note that since a portion of the lead (including the electrode array) 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 portion.

• 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: 9141698
• MDR Text Key: 160780258
• Report Number: 1644487-2019-01910
• 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: 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/05/2010
• Device Model Number: 302-20
• Device Lot Number: 200551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: 52 YR
• Patient Sex: Male