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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 302-30
Device Problems Fracture; Mechanical Problem
Event Date 08/12/2019
Event Type  Malfunction  
Event Description

Clinic notes were received for the patient indicating that the patient's device could not be interrogated due to battery depletion. Notes indicated that there was no discontinuities observed in the patient's lead on x-rays. The patient's generator was replaced due to the low battery. Upon replacement with the new generator, high impedance was observed. It was not seen on the previous generator as the previous generator could not be interrogated due to battery depletion the surgeon then found a kink in lead and sheathing gone. Due to lack of time, the surgeon could not replace the lead at that time. The explanted generator was discarded and the case ended without lead replacement. No further relevant information has been received to date. No known 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 Key8971360
Report Number1644487-2019-01733
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/06/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device EXPIRATION Date01/16/2009
Device MODEL Number302-30
Device LOT Number1530
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/09/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/20/2006
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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