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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
Event Date 12/20/2012
Event Type  Malfunction  
Event Description

It was reported by a vns implanting surgeon that during implantation of this patient's lead the green sutures came off of the anchor tethers and that the electrodes were coming off the nerve. Ultimately the electrodes stayed on the nerve and diagnostics performed were within normal limits. The surgeon asked if the leads had been made differently because of this and that he said that the electrodes looked like they were 'slightly tilted. ' this surgeon has been using the 304 leads for quite some time and has only used 2mm coils, except for in rare instances when the 3mm was needed. Review of manufacturing device history records for the helical lot used was performed to ensure that all assembly steps were signed off and there were no anomalies or unresolved defects/ncr's. It appears that the lead in this patient has met all specifications prior to shipment.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD MODEL 304
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
nydia herzog
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key2959687
Report Number1644487-2013-00395
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 01/15/2013
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/13/2013
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date05/31/2016
Device MODEL Number304-20
Device LOT Number3326
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received01/15/2013
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/02/2012
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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