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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR

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LIVANOVA USA, INC. PULSE GEN MODEL 106 GENERATOR Back to Search Results
Model Number 106
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 05/21/2018
Event Type  Injury  
Event Description

Further follow-up with the treating neurologist provided that the cardiac issues were not related to vns.

 
Manufacturer Narrative

 
Event Description

It was reported that the patient was hospitalized due to low heart rate. The cardiologist stated that the low heart rate correlated with magnet mode. However, the neurologist believed that the low heart rate was not caused by vns but could have been exacerbated by vns. No further relevant information has been received to date.

 
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Brand NamePULSE GEN MODEL 106
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 Key7594811
Report Number1644487-2018-01011
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation Physician
Type of Report Initial
Report Date 07/30/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Lay User/Patient
Device EXPIRATION Date11/13/2017
Device MODEL Number106
Device LOT Number4650
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/26/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/09/2015
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: 06/12/2018 Patient Sequence Number: 1
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