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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL UNK

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CYBERONICS, INC. LEAD MODEL UNK Back to Search Results
Event Date 06/24/2013
Event Type  Injury  
Event Description

Attempts for additional information from the initial reporter have been unsuccessful. No additional information was provided.

 
Event Description

During routine case management discussion with a mother who is considering vns implant for her child, the mother related a concern she heard about vns. A friend told her that her niece reportedly had stunted growth of the carotid artery and heart issues following implant of vns. No patient information or physician information was provided. Attempts for additional information from the reporter have been unsuccessful to date.

 
Manufacturer Narrative

 
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Brand NameLEAD MODEL UNK
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 Key3232904
Report Number1644487-2013-02166
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/24/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received10/10/2013
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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