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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 01/01/1998
Event Type  Injury  
Event Description

A case study titled ¿optimizing outcomes in refractory childhood epilepsy with vns therapy¿ was presented which included a vns patient who was experiencing painful stimulation and choking sensations months following vns implant surgery. The patient¿s device settings were very low and not high enough to perform system diagnostics. In (b)(6) 2013, an evoked potential test was performed but no abnormalities were observed. The patient underwent generator and lead replacement surgery on (b)(6) 2014. During the procedure, the surgeon noted that the vagus nerve was located more anteromedial to the common carotid arteries than expected possibly due to the large amount of fibrosis. The surgeon did not observe any issues with the patient¿s lead but noted that the electrodes were implanted more proximal to the nerve. The patient¿s physicians determined that the patient¿s issues were due to the electrodes being implanted too high and the nerve being superficial to the larynx. It was noted that the patient had been doing well with vns following the procedure.

 
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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 Key4461163
Report Number1644487-2015-03705
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Study,Health Professional,Company Representative
Reporter Occupation Health Professional
Type of Report Initial
Report Date 11/06/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/28/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/06/2014
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/10/2013
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: 01/28/2015 Patient Sequence Number: 1
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