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CYBERONICS - HOUSTON LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 01/01/2019
Event Type  Injury  
Event Description

It was reported via clinic notes received by the manufacturer that the patient's vns battery was dying and needed to be replaced. It was noted that the patient had complained of intermittent bleeding at the neck incision site. It was also stated that the patient had a nodule in his neck that the physician believed could possibly be a tangle of the vns lead wire. The impedance values were reported as within normal limits. The notes indicated that the patient was instructed to speak with the neurosurgeon regarding the nodule. No relevant surgery is known to have occurred to date. No additional relevant information has been received to date.

Event Description

It was later reported that the patient underwent vns generator replacement surgery and no lead replacement/intervention had occurred. Follow up with the company representative present at the surgery stated that it was not mentioned that there was anything other than a battery change due to an intensified follow-up indicator, or ifi, condition for the reason for surgery.

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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
MDR Report Key9168852
Report Number1644487-2019-01962
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/08/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number203931
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/20/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/05/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Date Received: 10/08/2019 Patient Sequence Number: 1