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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 03/20/2012
Event Type  Injury  
Event Description

Reporter indicated a patient had the vns lead "extended" surgically due to experiencing painful stimulation in the face when the head was turned. The reporter declined to provide any additional information at the time of the initial report, and all attempts to the reporter for additional information have been unsuccessful to date.

 
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Brand NameLEAD MODEL UNK
Type of DeviceLEAD MODEL UNK
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 grimes
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2513878
Report Number1644487-2012-00877
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Other,Company Representative
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 03/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2012
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? Yes
Event Location Other
Date Manufacturer Received03/20/2012
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

Patient TREATMENT DATA
Date Received: 04/02/2012 Patient Sequence Number: 1
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