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

Model Number 304-20

Device Problems Degraded (1153); High impedance (1291); Detachment of Device or Device Component (2907)

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

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Event Description

During a patient's generator replacement surgery it was noted that the silicone lead material was broken down, looked clear and "slimy," and was observed in the pocket and along the lead.The material had reportedly degraded and was detached from the lead wire.It was noted that the generator had the same material on it.The surgeon inspected the degradation upon explant of the generator and felt there may have been a bend or crease in the lead but was not certain.Pre-surgical diagnostics were noted to be normal with a lead impedance of 1427 ohms.This vns therapy system was completely explanted.The patient's re-implant is pending culture results on the explanted material, which have not been reported to the manufacturer.The explanted devices have been returned to the manufacturer and are currently undergoing product analysis.Attempts for additional relevant information have not been successful to date.

Event Description

The physician reported that the cultures came back negative for infection.Initial visual analysis by the manufacturer revealed abraded openings on the outer and inner silicone tubes.The outer insulation appeared to have been folded outward in one section.The abraded openings found on the outer and inner silicone tubes most likely provided the leakage path for the dried remnants of what appeared to have once been body fluids found inside the outer and inner silicone tubes.Isolated outer insulation abrasions were noted elsewhere on the lead.With the exception of the observed abraded openings, the condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure.No other obvious anomalies, beyond the outer and inner tubing openings, were noted.Note that since the electrode array section was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.The condition of the outer insulation and accumulation of body fluid inside the lead is the likely cause for the reported appearance of the lead at the time of surgery.There were no performance or any other type of adverse conditions found with the pulse generator.The battery measured 2.822 volts and showed an ifi=no condition.(b)(4).

Event Description

The patient's mothers reported that she suspects the cause for the fluid around the lead was due to the patient making rapid repeated head movements that may have caused a blister around the leads.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
• 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: 5101737
• MDR Text Key: 26840399
• Report Number: 1644487-2015-05872
• Device Sequence Number: 1
• Product Code: LYJ
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Followup,Followup
• Report Date: 02/26/2021

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: 09/30/2013
• Device Model Number: 304-20
• Device Lot Number: 201198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Supplement Dates Manufacturer Received: Not provided; 02/01/2021
• Supplement Dates FDA Received: 10/24/2015; 02/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2009
• 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: 13 YR