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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 04/01/2012
Event Type  Injury  
Event Description

Reporter indicated a patient had vns lead and generator replacement surgery performed on (b)(6) 2012 due to painful stimulation. The patient had an mri in the past that may have damaged the left vagus nerve per the reporter. The new vns lead was implanted on the right vagus nerve. The reporter and the surgeon were both aware of the manufacturer's labeling regarding not implanting the vns lead on the right vagus nerve. Attempts for further information and return of the explanted devices are in progress.

 
Manufacturer Narrative

 
Event Description

The explanted vns generator and lead were returned for analysis on (b)(6) 2013. Paperwork returned with the explants indicated the vns was replaced due to "lesion in nerve by mri". The condition of the returned lead portion is consistent with conditions that typically exist following an explant procedure. No obvious anomalies were noted. The setscrew marks found on the lead connector pin provide evidence that, at one point in time, a good mechanical and electrical connection was present. Continuity checks of the returned lead portions were performed, during the visual analysis, with no discontinuities identified. Based on the findings in the product analysis lab, there is no evidence to suggest an anomaly with the returned portions of the lead. Note that since a small portion of the lead assembly (body), including the electrode array section, was not returned for analysis, an evaluation and resulting commentary cannot be made on that portion of the lead. In the pa lab, the generator output signal was monitored for more than 24-hrs, while the generator was placed in a simulated body temperature environment. Results showed no signs of variation in the pulse generator's output signal and demonstrated that the device provided the expected level of output current for the entire monitoring period. The septum was not cored, eliminating the possibility of a potential unintended electrical current path through body fluids. The pulse generator diagnostics were as expected for the programmed parameters. The generator performed according to functional specifications. During the product analysis there were no anomalies found with the pulse generator. All attempts to the reporter for additional information have been unsuccessful to date.

 
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Brand NameLEAD MODEL 302
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2916436
Report Number1644487-2013-00161
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/20/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/15/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date12/31/2011
Device MODEL Number302-20
Device LOT Number200985
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/18/2013
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/18/2013
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured12/18/2008
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: 01/15/2013 Patient Sequence Number: 1
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