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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 303

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LIVANOVA USA, INC. LEAD MODEL 303 Back to Search Results
Model Number 303-20
Device Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 05/06/2018
Event Type  Malfunction  
Event Description

High lead impedance was observed on a patient's vns system during a follow-up visit. The physician elected to perform surgery to replace the patient's generator, as the battery was low, and planned to replace the lead upon evaluating its status at surgery. X-ray images were taken of the system prior to surgery, but the physician did not observe any lead discontinuities in the images. Upon explanting the generator during surgery, the physician observed that the lead was tangled and decided to replace the lead also. The physician observed a fracture in the lead after it was explanted. The physician reviewed the x-ray images again and observed that the fracture was actually visible in the images. The physician was unsure whether patient manipulation contributed to the lead fracture. X-ray images from several clinic visits were received by the manufacturer, but have not been reviewed to date. The explanted lead and generator have not been received by the manufacturer to date. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 303
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 Key7753753
Report Number1644487-2018-01338
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 09/23/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/06/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2017
Device MODEL Number303-20
Device LOT Number3738
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/31/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/04/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/10/2013
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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