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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 05/30/2017
Event Type  Malfunction  
Event Description

A neurologist observed a low impedance error message when she interrogated the patient's device. The patient underwent full revision surgery. The surgeon believed that the original lead may have slipped off the patient's nerve, resulting in the low impedance. The explanted lead and generator were not returned for analysis. No additional 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 Key6663167
Report Number1644487-2017-04031
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 06/23/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/23/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2015
Device MODEL Number304-20
Device LOT Number3022
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/30/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/07/2011
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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