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U.S. Department of Health and Human Services

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

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LIVANOVA USA, INC. PULSE GEN MODEL UNK GENERATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Death  
Event Description

It was reported that during a visit to a developmental home, the company representative was approached by a woman who informed him that the vns had "fried her niece's heart and killed her. " the woman walked away immediately and no further information was provided. No additional relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL UNK
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 Key7958253
Report Number1644487-2018-01817
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Type of Report Initial
Report Date 10/11/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/11/2018
Is This An Adverse Event Report? Yes
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received09/27/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 10/11/2018 Patient Sequence Number: 1
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