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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 Fracture
Event Date 06/11/2018
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that a vns patient¿s device had been programmed off because it was "misfiring", and the lead was not working, and a full revision was scheduled. High lead impedance was observed prior to surgery, and also during the surgery when the new generator was connected to the lead. The lead was reportedly tangled and kinked, and the lower electrode had become detached from the nerve. Full revision surgery occurred. The explanted devices were received. Analysis is underway, but has not been completed 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 Key7714030
Report Number1644487-2018-01251
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 09/10/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/24/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203686
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/19/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/10/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/27/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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