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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. LEAD MODEL 304

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CYBERONICS, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Mechanical Problem
Event Date 12/21/2016
Event Type  Malfunction  
Event Description

It was reported that in an initial implant case, the second electrode of the lead appeared to be bent and have a metallic "foil-looking substance" wrapped around it. The issue was immediately discovered as the implanting surgeon was attempting to wrap the electrode around the vagus nerve. The implanting and attending surgeons observed that it appeared the lead had ¿extra coiling. ¿ by their account, there was apparently extra material, as if it was thicker than normal. The lead device history record was reviewed and found that all specifications were met prior to distribution. The lead was not implanted and was returned to the manufacturer. Product analysis on the lead is underway.

 
Event Description

Product analysis for the returned lead was completed. The closest electrode to the bifurcation was damaged, showing bends on the electrode ribbon and partial detachment from the silicone helix. This silicone helix also exhibits what appear to be tool imprints. The most likely reason for the observed damaged to the closest electrode was manipulation of the lead not consistent with vns labeling. The measured dimensions were within the specified tolerances. Resistance values were within tolerances and exhibited no evidence of discontinuities. Other than the above mentioned observations and typical conditions that exist after a surgical procedure, no anomalies were identified in the returned lead.

 
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Brand NameLEAD MODEL 304
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 Key6252939
Report Number1644487-2017-03037
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/17/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/15/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number304-20
Device LOT Number203892
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/30/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received01/25/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/22/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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