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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 Mechanical Problem
Event Date 05/07/2018
Event Type  Malfunction  
Event Description

It was reported that during surgery the surgeon was attempting to implant patient, and he was not able to place the positive electrode on the nerve. The surgeon claimed that the electrode was too tight, and he was unable to get it to uncoil in order to place it on the nerve. The surgeon did not believe there was anything abnormal about the patient's anatomy that caused the difficulty, and when a new lead was opened, the surgeon was able to quickly implant the patient with no issues. A review of device history records showed that the implanted lead passed all other quality prior to distribution. The suspect lead was received for analysis; however, analysis has not 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
njemile crawley
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key7562990
Report Number1644487-2018-00919
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 06/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/01/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number304-20
Device LOT Number204208
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/22/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received06/05/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/16/2017
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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