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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS LEAD MODEL 304

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CYBERONICS LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 06/11/2014
Event Type  Malfunction  
Event Description

It was reported that a patient had undergone surgical lead revision on (b)(6) 2015 due to high impedance and that stimulation pulses were not perceived. The impedance following the lead replacement was reported to be correct. It was reported that high impedance had been observed on (b)(6) 2014. Review of programming history found that the pulse generator was enabled on (b)(6) 2014. No diagnostics were performed on that date. System diagnostics on (b)(6) 2014 resulted in high impedance, dcdc 7, neos no. It was reported that the suspected cause of high impedance was a wrong implant site of the lead electrodes. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted lead has not been returned to date.

 
Manufacturer Narrative

Device manufacturing records and available programming and diagnostic history were reviewed. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
CYBERONICS, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4549105
Report Number1644487-2015-03974
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/02/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/26/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/31/2017
Device MODEL Number304-20
Device LOT Number202627
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/02/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/21/2013
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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