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U.S. Department of Health and Human Services

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

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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.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
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 Key7650646
Report Number1644487-2018-01095
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
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

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