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

Model Number 304-20

Device Problems Corroded (1131); Fracture (1260); Device Contamination with Body Fluid (2317)

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

Event Date 12/01/2018

Event Type  malfunction  

Event Description

It was reported from an implant received that a patient had a full vns replacement due to high impedance.Device history record was reviewed for the lead.The lead passed all specifications prior to distribution into the field.Additional details indicated that the neurologist identified high impedance in an adjustment and referred it to the neurosurgeon.In the same week, a new vns kit was requested to be carried out to review the system, and the physician opted for the complete replacement of the equipment.Electrode returned with silicone rupture and physician opted for full exchange since the battery was near the end.The explanted device has not been received for analysis to date.

Manufacturer Narrative

(b)(4).

Event Description

The lead was received for analysis.Analysis is underway but has not been completed to date.No additional or relevant information has been received to date.

Event Description

Product analysis for the lead was completed and approved.Abraded openings were noted in the outer and the inner silicone tubing.The reported fracture of leads was verified by product analysis.A break was identified in the positive coil.Scanning electron microscopy images show that pitting or electro etching conditions occurred at the break location.Appearance of the positive quadfilar coil broken mate end suggests a stress-induced fracture (fatigue) occurred in at least three strands.Since a portion of the lead (including the electrode array portion) was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.

• 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: rachel kohn ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 8399775
• MDR Text Key: 138113601
• Report Number: 1644487-2019-00432
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 05425025750139
• UDI-Public: 05425025750139
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 05/16/2019

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: 02/15/2020
• Device Model Number: 304-20
• Device Lot Number: 203705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: 02/12/2019
• Initial Date FDA Received: 03/07/2019
• Supplement Dates Manufacturer Received: 03/26/2019; 04/19/2019; 04/22/2019
• Supplement Dates FDA Received: 04/18/2019; 04/19/2019; 05/16/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/18/2016
• 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: 12 YR