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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 11/15/2018
Event Type  Malfunction  
Event Description

Initial report was that a patient was referred for replacement due to eos. Further information was received that the patient's generator was replaced due to high impedance. The patient's neurologist did not feel that the lead was compromised but that the high impedance was due to the upgraded tablet software and the fact that the patient had a m102 device. The neurologist stated in his notes to the surgeon that the impedance was higher than normal and that the surgeon should visually inspect and try a new generator before replacing the lead. Per the received implant card, only the patient's generator was replaced. For model 102/102r generators programmed to output currents > 1 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. This is likely what the physician was referring to when indicating that he believed the upgraded tablet software was the cause of the high impedance. The generator has not been received to date. No other 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 Key8216840
Report Number1644487-2018-02316
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 03/04/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/04/2019
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? Device Returned To Manufacturer
Date Returned to Manufacturer02/08/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Other
Date Manufacturer Received02/08/2019
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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