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

Model Number 304-20

Device Problem Mechanical Problem (1384)

Patient Problems Pain (1994); Neck Pain (2433)

Event Date 06/26/2017

Event Type  malfunction  

Event Description

It was reported that the patient was scheduled for a full revision.It was reported that since the time of the patient¿s battery replacement in (b)(6) 2017, the patient has complained of intermittent shocking pain that travels from his armpit area up to his lateral left neck and only occurs when the vns is on.The device was turned off and the events stopped.X-rays were stated to show nothing.The patient underwent a full replacement.The surgeon state that the lead insulation near the generator was no longer present, causing the wires to be exposed.This was the area the patient was feeling the shocking sensations.System diagnostics were performed before surgery and impedance was ok.The generator was on prior to the surgery staring.It was stated he was on rapid cycling according to the surgeon¿s notes.However it was stated he was in patient for an emu stay at some point in the last 24 hours and his settings were changed.The explanted generator and lead were 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 on the lead was completed and approved on (b)(4) 2018.An analysis was performed on the returned lead portions.Note that the anchor tether helical and suture was not returned for analysis and therefore a complete evaluation could not be performed on the entire lead product.The condition of the returned lead portions is consistent with conditions that typically exist following an explant procedure.No obvious anomalies were noted.The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present.Continuity checks of the returned lead portion were performed, during the visual analysis, and no discontinuities were identified.Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the device which may have contributed to the stated complaints.Note that since the anchor tether helical and suture was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead.Product analysis for the generator was completed and approved.The device output signal was monitored for more than 24-hrs, while the pulse generator was placed in a simulated body temperature environment.Results showed no signs of variation in the pulse generator¿s output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period.The pulse generator diagnostics were as expected for the programmed parameters.There were no performance or any other type of adverse condition found with the pulse generator.

• 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: njemile crawley ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2812287200
• MDR Report Key: 7650646
• MDR Text Key: 112743769
• Report Number: 1644487-2018-01095
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/01/2015
• Device Model Number: 304-20
• Device Lot Number: 201934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Other
• Date Manufacturer Received: 07/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2011
• 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: 16 YR