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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 Problem Detachment of Device or device Component
Event Date 12/10/2018
Event Type  Malfunction  
Event Description

It was reported that during replacement surgery, new devices were tested outside of the pocket, impedance was normal and then the surgeon was unable to get the set screw driver to disengage the lead terminal pin from the generator. Ultimately a new lead and generator had to be implanted. The new lead's electrodes were successfully implanted onto the vagus nerve and the terminal pin was connected to new device 106 (while still out of the pocket). After successful system diagnostic testing, the neurosurgeon tried to remove the lead from the header of the device and could not do so. The neurosurgeon said the he ¿could not back out the setscrew. ¿ a new system was successfully implanted in the patient. The lead tubing was seen disconnected near the area where the led pins are inserted into the generator. The device have not received to date. No additional or relevant information has been 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8218897
Report Number1644487-2019-00011
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 02/20/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number304-20
Device LOT Number5735
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/18/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/11/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured05/16/2018
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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