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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 01/15/2015
Event Type  Malfunction  
Event Description

It was reported that he patient underwent surgical revision on (b)(6) 2015 for lead replacement due to lead discontinuity and a prophylactic generator replacement. The lead impedance of the newly implanted system was reported to be ok, 1213 ohms. The explanted devices have not been returned to date.

 
Event Description

It was reported that the vns patient¿s device showed high impedance during an office visit on (b)(6) 2015. The patient was referred for surgery but no known surgical interventions have occurred to date. Review of the available programming and diagnostic history showed normal diagnostic results through (b)(6) 2011.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. Device manufacturing records 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 302
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 Key4502462
Report Number1644487-2015-03801
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup
Report Date 01/16/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/10/2015
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 Number302-20
Device LOT Number201272
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/24/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/17/2009
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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