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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Event Date 03/17/2015
Event Type  Malfunction  
Event Description

It was reported that the vns patient had undergone a full vns system replacement on (b)(6) 2015 due to lead discontinuity. System diagnostics on the new vns system returned lead impedance within normal limits, 1801 ohms. Review of the available programming and diagnostic history showed diagnostics results within normal limits through (b)(6) 2012. Review of manufacturing records confirmed that the lead passed all functional tests prior to distribution. The explanted generator and lead have not been received for analysis to date.

 
Event Description

Further information was received indicating that the generator was replaced prophylactically, as it had been implanted for four years. Furthermore, the old lead was implanted on the right side, and the new one was implanted on the left side, and the surgeon considered it was more practical and safer to implant a new generator. A lead fracture was obvious on the old lead, approximately 10 cm distal to the generator connection. The explant of the lead did not include the electrode array.

 
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. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS, INC.
100 cyberonics blvd
houston TX 77058 770
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 Key4738799
Report Number1644487-2015-04576
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/10/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/30/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/30/2013
Device MODEL Number304-20
Device LOT Number2506
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received05/05/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/11/2009
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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