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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS INC LEAD MODEL 302

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CYBERONICS INC LEAD MODEL 302 Back to Search Results
Model Number 302-20
Event Date 12/15/2005
Event Type  Injury  
Event Description

Initially, it was reported that during a vns system replacement surgery, it was observed that the patient's left vagus nerve was cut and that it presented with signs of having been cut for a long period of time. A neuroma was observed at the level of the cut which was at the lower end of the vagus nerve. No relationship of the cut to vns was noted at the time of initial report. It was later reported during a neurosurgeon expert meeting, that the diagnosis of a complete cut left nervus vagus with a neuroma was made during the replacement surgery. It was noted that the lesion was probably due to direct surgical trauma during the first implant procedure. It was noted that the patient had experienced partial improvement of epilepsy with vns therapy.

 
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Brand NameLEAD MODEL 302
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 Key3774040
Report Number1644487-2014-01121
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/20/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date06/30/2008
Device MODEL Number302-20
Device LOT Number1164
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/20/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured06/28/2005
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: 04/25/2014 Patient Sequence Number: 1
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