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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON BIPOL LEAD MODEL 300

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CYBERONICS - HOUSTON BIPOL LEAD MODEL 300 Back to Search Results
Model Number 300-20
Device Problems Detachment of Device or device Component; Adverse Event Without Identified Device or Use Problem
Event Date 08/24/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported that the patient was feeling irritation in her neck and that the physician had taken x-rays of the neck. It was stated that the physician believed that the electrodes had migrated. The physician wanted to disable the vns to reduce the irritation. The x-rays have not been reviewed by the manufacturer to date. No additional relevant information has been received to date.

 
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Brand NameBIPOL LEAD 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 Key7887044
Report Number1644487-2018-01643
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/07/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/18/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/31/2001
Device MODEL Number300-20
Device LOT Number19504C
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/18/1999
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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