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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL UNKNOWN

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CYBERONICS INC LEAD MODEL UNKNOWN Back to Search Results
Event Date 11/23/2012
Event Type  Malfunction  
Event Description

During review of programming and diagnostic history, it was observed that the vns patient¿s device was tested on (b)(6) 2012 and system diagnostic results revealed high impedance (impedance value >= 10,000 ohms). The high impedance condition resolved the following day. No patient adverse events were reported.

 
Manufacturer Narrative

Review of the available programming and diagnostic history. Device failure is suspected, but did not cause or contribute to a death or serious injury.

 
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Brand NameLEAD MODEL UNKNOWN
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 Key4519439
Report Number1644487-2015-03852
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/21/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received01/21/2015
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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