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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: LIVANOVA USA, INC. PROGRAMMING SOFTWARE

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LIVANOVA USA, INC. PROGRAMMING SOFTWARE Back to Search Results
Model Number MODEL 3000
Device Problem Computer Software Problem
Event Date 12/26/2018
Event Type  Malfunction  
Event Description

It was reported that the physician ran diagnostics on the patient's vns and it was stated that it looked like there were lead issues. High impedance was observed on the patient's m102 vns generator when using the physician's m3000 v1. 5. 2. 1 vns programming system with a dcdc code of 4. However, diagnostics with a motion vns programming tablet revealed that the high impedance reading was false. This issue was duplicated with in-house testing. For model 102/102r generators programmed to output currents greater than 1. 00 ma , it was observed that system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5 software would display a false high impedance. It was determined that the cause of this false high impedance message was a software error on m3000 v1. 5. 2. 1 software; when system diagnostics were performed by the user with m3000 v1. 5. 2. 1 software on m102/102r generators (normal mode output current;0 ma), normal mode diagnostics would actually be performed instead. The execution of normal diagnostics instead of system diagnostics is not apparent to the user, and the returned dcdc code was being compared against system diagnostic thresholds. No additional relevant information has been received to date.

 
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Brand NamePROGRAMMING SOFTWARE
Type of DevicePROGRAMMING SOFTWARE
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 Key8262486
Report Number1644487-2019-00102
Device Sequence Number1
Product CodeMUZ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Notification
Type of Report Initial
Report Date 03/12/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/18/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device MODEL NumberMODEL 3000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received03/12/2019
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

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