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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 09/01/2009
Event Type  Injury  
Event Description

It was reported to the manufacturer that the vns patient's electrodes moved and has been experiencing discomfort in the neck region. It is unknown at this time how the migration condition was detected. The patient is scheduled for a full revision of the device for the reported event. Good faith attempts to obtain additional information regarding the reported event have been unsuccessful to date.

 
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Brand NameLEAD MODEL UNKNOWN
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
houston , TX 77058
2812287200
MDR Report Key1491033
Report Number1644487-2009-02220
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 09/03/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/02/2009
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
Date Manufacturer Received09/03/2009
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: 10/02/2009 Patient Sequence Number: 1
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