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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 304

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LIVANOVA USA, INC. LEAD MODEL 304 Back to Search Results
Model Number 304-20
Device Problems Fracture; Device Contamination with Body Fluid
Event Date 07/06/2018
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

High impedance was observed on a patient's device. A lead revision surgery was performed for the impedance issue, and was placed on the right vagus nerve as the left nerve could not be found due to patient anatomy. The generator was not changed, and post-operation diagnostics indicated ok impedance. This was reported in mfg report #1644487-2018-00771. It was later reported that about two weeks after the surgery, high impedance was noted again and the physicians believed there may be an issue with the generator. It was stated that the patient was not very active, so it was not likely any trauma occurred to the site. It was unknown if the patient manipulated the device. A generator replacement, and possible full revision, surgery was scheduled. The surgery occurs and it was noted that various troubleshooting was performed, including lead pin reinsertion and testing the generator with a test resistor. Both the lead and generator were replaced, and post-operation diagnostics indicated ok impedance. It was reported by the representative at the surgery that fluid was found in the tubes of the lead. Device history records were reviewed for the explanted devices and each device was indicated to have passed all quality inspections prior to distribution. No explanted devices were returned to date. No additional information was received to date.

 
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Brand NameLEAD MODEL 304
Type of DeviceLEAD
Manufacturer (Section D)
LIVANOVA USA, INC.
100 cyberonics blvd
houston TX 77058
Manufacturer (Section G)
LIVANOVA USA, INC.
100 cyberonics blvd
suite 600
houston TX 77058
Manufacturer Contact
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7692269
Report Number1644487-2018-01195
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 08/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/16/2018
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 Number204037
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received08/29/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/01/2017
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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