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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. LEAD MODEL 302

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LIVANOVA USA, INC. LEAD MODEL 302 Back to Search Results
Model Number 302-20
Device Problem Fracture
Event Date 12/27/2018
Event Type  Malfunction  
Event Description

It was reported that high impedance was detected on the patient's generator. X-rays were reviewed by the manufacturer. Per the x-rays, although the angle of the image makes it impossible to visualize the pin past the second connector block, based on the ridges in the lead pin compared to the connector blocks, the lead pin is likely fully inserted. Strain relief was not per labeling. No apparent gross lead fractures were observed; however, there was a sharp angle in the lead below the electrodes. The cause of the patient¿s high impedance could not be determined based on the images provided. Note that the presence of a micro-fracture and/or a lead could not be ruled out. Data review confirmed that high impedance had been detected on the generator. No known relevant surgical intervention has occurred to date. No further relevant surgical intervention has occurred to date.

 
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Brand NameLEAD MODEL 302
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 Key8932651
Report Number1644487-2019-01658
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/01/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/26/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/14/2013
Device MODEL Number302-20
Device LOT Number2456
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received10/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/29/2009
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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