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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 01/15/2013
Event Type  Malfunction  
Event Description

It was reported that the patient was having a vns full revision for an unknown reason. Information was received that the reason for the revision was due to battery depletion, but no reason for the lead revision was given. The patient had a full revision on (b)(6) 2013 and the products were returned to the manufacturer on (b)(6) 2013 for product analysis. Product analysis was conducted on the lead and a coil break was found in the positive and negative portions of the lead along with corrosion. There was no performance issues found with the vns generator. Attempts to contact the physician have been unsuccessful to date. The device history report for the lead was reviewed and no non conformances were found.

 
Manufacturer Narrative

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

 
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Brand NameLEAD MODEL 302
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key3094049
Report Number1644487-2013-01033
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/08/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/06/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2014
Device MODEL Number302-20
Device LOT Number201406
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/05/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/08/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/19/2005
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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