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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 300

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CYBERONICS - HOUSTON LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 11/19/2018
Event Type  Injury  
Manufacturer Narrative

Adverse events caused by the surgical procedure are not related to functionality of the vns.

 
Event Description

It was reported that a lead revision due to high impedance had to be aborted due to complications. The high impedance event is captured in mdr #1644487-2018-01964. The surgeon reported that the patient's electrode coils had formed scar tissue due to the initial lead implant that had attached to the jugular vein. It was reported that when the surgeon would attempt to manipulate the vagus nerve the jugular vein would suffer "small cracks" and bleed. After a long time trying to form open space on the nerve to implant another lead, the surgeon became concerned for the patient's health due to the bleeding. As a result he made the decision not to proceed with the lead or generator replacement. No additional relevant information has been received to date.

 
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Brand NameLEAD MODEL 300
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS - HOUSTON
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS - HOUSTON
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8166999
Report Number1644487-2018-02302
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 12/14/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/14/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/23/2003
Device MODEL Number300-20
Device LOT Number2747
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/19/2018
Was Device Evaluated By Manufacturer? No
Date Device Manufactured03/23/2003
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: 12/14/2018 Patient Sequence Number: 1
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