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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS - HOUSTON LEAD MODEL 304

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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem High impedance
Event Date 12/11/2018
Event Type  Malfunction  
Event Description

It was reported that high impedance was seen on this patient's device. It was reported that this patient was recently implanted with the vns device. The patient's output current was disabled due to the high impedance. The patient has been referred for surgery. The doctor was not able to make an assessment on the believed cause of the high impedance. X-rays were reviewed by the manufacturer where an image of the generator was provided, and the connector pin cannot be seen coming through the second connector block. The angle of the generator in the image also made it difficult to make a clear assessment of the pin insertion. The filter feedthru were confirmed to be intact. No sharp angles or gross discontinuities were identified in the visible portion of the lead. No known surgical intervention has occurred to date. No other relevant information has been received to date.

 
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Brand NameLEAD MODEL 304
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 Key8211885
Report Number1644487-2019-02402
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 01/03/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/03/2019
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 Number204433
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/11/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/03/2018
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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