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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 Problems Corroded ; Fracture; Device Contamination with Body Fluid
Event Date 03/03/2019
Event Type  Malfunction  
Event Description

It was reported that during follow-up it was found that the patient had high impedance with a low output current. The physician was recommended to turn the device off and refer the patient for x-rays. Anterior posterior electrode close up x-rays were received and reviewed. The generator placement was determined to be normal in the left chest. Based on the scope of the image, the feed through wires were intact, however the pin could not be visualized passed the second connector pin per the scope and angle of the image. The lead was visualized in the chest and neck. The strain relief loop and the strain relief bend did not appear to be present per labeling. Tie downs could not be visualized per the quality of the image. Based on the scope and quality of the image, it appears the lead is routed behind the generator. It could not be assessed if the lead wires were intact at the connector pin per the quality of the image. The lead was assessed for fractures and no gross fractures or discontinuities were noted, however a portion of the lead appeared to be tangled near the connector pin. Based on the x-rays received, the cause for the high impedance cannot be determined at this time, however based on the evidence of the lead being tangled the cause is possibly from manipulation of the lead. The presence of a fracture or micro-fracture in the lead cannot be ruled out. No surgical intervention has been reported to date. No additional 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8705255
Report Number1644487-2019-01155
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 08/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/01/2019
Device MODEL Number304-20
Device LOT Number300306
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/09/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/30/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/05/2015
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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