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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 Problems Computer Software Problem; Incorrect, Inadequate or Imprecise Result or Readings
Event Date 09/25/2018
Event Type  Malfunction  
Event Description

It was found during periodic history review that high impedance was detected on a patient¿s m102 generator with m3000 version 1. 5. 2. 1 programming system. It was previously determined through in-house testing that, for model 102/102r generators programmed to output currents > 1ma, system diagnostics using m3000 v1. 0 and m250 software would display ok lead impedance while system diagnostics using m3000 v1. 5. 2. 1 software would display a false high impedance. The cause of these false high impedance messages was a software error on m3000 v1. 5. 1. 2 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. As the patient's replacement was stated to be due to battery depletion and the lead was not replaced, it is assumed that the patient's replacement was not due to high impedance. The lead impedance was within normal limits when a new generator was implanted. No further 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 Key8262691
Report Number1644487-2019-00095
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 01/18/2019
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 HEALTH PROFESSIONAL
Device MODEL NumberMODEL 3000
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received12/28/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/18/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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