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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 Date 04/10/2018
Event Type  Injury  
Event Description

A research article hypothesized the risk factors to determine a relationship between vns and clinically-significant arrhythmias. The case study central to the article discussed a patient who was admitted to the facility with symptomatic bradycardia associated with vns stimulation. The patient's medical history was reviewed. It was noted that the patient did not exhibit heart rate changes related to vns stimulation during the vns implant procedure; however, 3 years after implant, the patient occasionally exhibited loss of consciousness initially presumed to be related to a change in seizure type. It was later determined that the patient experienced momentary bradycardia, av block, and a brief cardiac arrest during sleep. The patient was implanted with a cardiac pacemaker, which resolved the bradycardia. Previous literature was also reviewed in the context of this article. The literature review identified 21 patients documented across 14 studies exhibited arrhythmias presumably induced by vns. Several of these events are discussed in the following mfr. Report #s: 1644487-2014-01653, 1644487-2006-00148, 1644487-2008-01907, 1644487-2008-01792, 1644487-2008-01919, 1644487-2009-01201, 1644487-2008-01648, 1644487-2008-03112, 1644487-2009-02887, 1644487-2011-01081, 1644487-2011-01081, 1644487-2012-02233, 1644487-2012-00993.

 
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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 Key7779058
Report Number1644487-2018-01386
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,L
Reporter Occupation
Type of Report Initial
Report Date 07/18/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/13/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received07/18/2018
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: 08/13/2018 Patient Sequence Number: 1
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