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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problem Fracture
Event Date 04/30/2019
Event Type  Malfunction  
Event Description

It was reported that high impedance was seen on a patient's device. It was also reported that all of the patient's output currents were programmed off. Additional information was received that per the neurosurgeon, it was assumed that it was in a dance class that she felt something had happened on the generator. Photos of the patient's ap and lateral neck and chest x-rays were also received and reviewed and revealed that the cause of the high impedance is likely lead fracture, as it does appear that the leads are coiled which can lead to a lead discontinuity as well as a possibly discontinuity visualized. Device history records were reviewed on and the device passed all functional specifications and quality tests and were sterilized prior to distribution. Though surgery is likely, no surgical intervention has been reported to date. No additional relevant information has been received to date.

Event Description

Information was received that there was no high impedance seen with the old generator and new lead. It was stated the generator was changed first, and then after changing the generator and checking the generator they saw high impedance. It was observed at this time that the lead was damaged and there it was replaced. A generator diagnostic was not run with the new generator. The lead and generator have been discarded. No additional relevant information has been received to date.

Event Description

The patient had a full explant of the vns system. The explanted devices have not been received to date.

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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 Key8633801
Report Number1644487-2019-00991
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/19/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/22/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL Number304-20
Device LOT Number4935
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/02/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured07/21/2016
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial