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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 103 GENERATOR Back to Search Results
Model Number 103
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 09/26/2018
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that a patient is experiencing asystole when the magnet is activated for 15 seconds after the magnet swipe. The patient is reported to be diagnosed with aortic stenosis and rheumatic heart disease. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 103
Type of DeviceGENERATOR
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 Key7980947
Report Number1644487-2018-01852
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation Physician
Type of Report Initial
Report Date 11/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/18/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date11/29/2014
Device MODEL Number103
Device LOT Number202360
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received11/06/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/08/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/18/2018 Patient Sequence Number: 1
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