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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; Adverse Event Without Identified Device or Use Problem
Event Date 04/14/2018
Event Type  Malfunction  
Event Description

It was reported that a vns patient was scheduled for generator replacement due to battery depletion. The communication was reported to be okay prior to generator replacement, but after the generator replacement high impedance was found. The surgeon found a broken electrode. A new electrode was installed, and the patient was in good condition with impedance measurements within normal limits of 1,416, 1,562, and 1,445 ohms. The explanted devices were received and analysis is underway, but has not been completed to-date. Additional relevant information 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 Key7500445
Report Number1644487-2018-00751
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 07/31/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2016
Device MODEL Number304-20
Device LOT Number202249
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/07/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/23/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2012
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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