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

Model Number 302-20

Device Problems Fluid/Blood Leak (1250); Fracture (1260)

Patient Problem Pain (1994)

Event Date 07/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient's generator and lead were explanted because the patient claimed that the vns was shocking her.The explanted lead and generator were returned.Product analysis was completed on the returned portion of the lead.A portion of the lead and the electrodes were not returned and thus, could not be evaluated.Multiple abraded openings were noted on the outer and the inner silicone tubing of the returned lead portions.Fluid within the inner and outer tubing was also identified with no other point of entry besides the abraded openings and cut ends.No further anomalies or any discontinuities were identified.No further relevant information has been received to date.

Event Description

Product analysis was completed on the returned generator.The generator was monitored for 24 hours in a simulated body temperature environment.The generator provided the intended output current for the entirety of the monitoring period.A comprehensive electrical evaluation showed that the device performed according to functional specifications.Per the internal data of the generator, high impedance was detected prior to device explant.No further relevant information has been received to date.

Event Description

It was reported that when high impedance was detected, the patient's generator was disabled.In addition, x-rays of the patient's neck taken after explant were received and reviewed.Only a small portion of the lead (including the electrodes) was left implanted per the images.There was no evidence of a lead fracture in this portion of the lead.However, this does not rule out the possibility of microfractures.No further relevant information has been received to date.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7139918
• MDR Text Key: 95626064
• Report Number: 1644487-2017-05066
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/17/2014
• Device Model Number: 302-20
• Device Lot Number: 201322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2010
• 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 Outcome(s): Required Intervention
• Patient Age: 39 YR