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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Mechanical Problem
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.

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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key7650646
Report Number1644487-2018-01095
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
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 Received06/29/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/01/2015
Device MODEL Number304-20
Device LOT Number201934
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/21/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/02/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/02/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 06/29/2018 Patient Sequence Number: 1