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U.S. Department of Health and Human Services

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

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LIVANOVA USA, INC. PROGRAMMING SOFTWARE; PROGRAMMING COMPUTER Back to Search Results
Model Number MODEL 3000
Device Problems False Alarm (1013); Fracture (1260); Application Program Problem: Parameter Calculation Error (1449)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/07/2019
Event Type  malfunction  
Event Description
Programming history database periodic review was performed and confirmed a high impedance event for the patient.High impedance was seen on.Patient underwent generator replacement but no known lead replacement has occurred to date.No additional relevant information has been received to date.
 
Event Description
High impedance was observed when v1.5 software was used on a m102 generator.System diagnostics were initially performed which caused the false high impedance to be observed.The impedance was likely stored from the previous system diagnostics.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.
 
Manufacturer Narrative
B5.Corrected information, section d corrected information; information inadvertently omitted that was known prior to submission of mdr.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING COMPUTER
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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key12804809
MDR Text Key285411504
Report Number1644487-2021-01576
Device Sequence Number1
Product Code LYJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/30/2015
Device Model NumberMODEL 3000
Device Lot Number2940
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 10/20/2021
Initial Date FDA Received11/12/2021
Supplement Dates Manufacturer Received12/20/2021
Supplement Dates FDA Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/18/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age34 YR
Patient SexMale
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