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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 304-30
Event Date 12/02/2014
Event Type  Malfunction  
Event Description

It was reported that the patient had prophylactic generator replacement. During the operation, the surgeon found that some of the "lead was exposed" from the insulation. The surgeon proceeded to patch the exposed segment with tubing, and the lead was not replaced. Pre-operative and post-operative diagnostics were reported to be within normal limits.

 
Manufacturer Narrative

Manufacturer device history records were reviewed. Review of the lead device history records confirmed all quality specifications were passed prior to distribution with no non-conformances noted.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
CYBERONICS INC
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 Key4343446
Report Number1644487-2014-03406
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 12/05/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/18/2014
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date07/31/2016
Device MODEL Number304-30
Device LOT Number202169
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received12/05/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/02/2012
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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