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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 03/08/2019
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that this patient experienced a bradycardia event. The doctor requested that the patient¿s device¿s output current be disabled so that the surgeon could perform an oral cavity surgery on the patient (which was approved by the patient¿s neurosurgeon). The patient¿s output current was successfully disabled prior to surgery. After surgery the settings were returned to their original settings. At this time the patient¿s heart rate decreased from 70 bpm to 35 bpm, which was suspected to be due to stimulation. At the discretion of the surgeon who performed the oral cavity the output current was decreased (not disabled) to 1. 5ma, at which point there was no change in heart rate during stimulation. No system diagnostics had been performed prior to surgery. No further 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
rachel kohn
100 cyberonics blvd
suite 600
houston , TX 77058
2812287200
MDR Report Key8497210
Report Number1644487-2019-00685
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 05/31/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/09/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date11/19/2016
Device MODEL Number103
Device LOT Number203205
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received05/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/22/2014
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: 04/09/2019 Patient Sequence Number: 1
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