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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
Device Problem High impedance
Event Date 05/27/2013
Event Type  Malfunction  
Event Description

During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested during an office visit on (b)(6) 2013 and system diagnostic results revealed high impedance (dc dc ¿ 7). No patient adverse events were reported.

 
Manufacturer Narrative

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

 
Event Description

An implant card was received indicating that the patient underwent generator and lead replacement surgery on (b)(6) 2015. The explanting facility discarded the explanted device; therefore, no analysis can be performed.

 
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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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key4528439
Report Number1644487-2015-03900
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE,HEA
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/23/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/19/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date08/31/2008
Device MODEL Number302-20
Device LOT Number1257
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/27/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/25/2005
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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