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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 Low impedance
Event Date 08/30/2017
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was found in programming history that there was evidence of fluctuating lead impedance levels, indicating a short circuit or low impedance condition. No additional information has been received.

 
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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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8392232
Report Number1644487-2019-00421
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 03/05/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date03/10/2017
Device MODEL Number304-20
Device LOT Number202439
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Device Age5 yr
Event Location Other
Date Manufacturer Received02/10/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/12/2013
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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