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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 3000
Device Problems Application Program Problem: Parameter Calculation Error (1449); Therapeutic or Diagnostic Output Failure (3023)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2023
Event Type  malfunction  
Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanovas employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any defects¿ or malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
 
Event Description
It was reported that an error of high output current was displayed upon interrogating the patients device.The error message noted that the current could not be delivered.It was noted that after re-interrogation, the error went away.It was noted that this error occurred right when device turned from night to daytime settings.Additional information was received noting that the event occurred following a change in day/night settings while the generator was stimulating and that the active output is different from the alternative output currents for day and night settings.Device history records were reviewed for the generator.The device passed all functional specifications and quality tests and were sterilized prior to distribution.No other relevant information has been received to date.
 
Event Description
Internal generator data was reviewed.The high output current was observed due to the software expecting a 1.5ma output current as the device was initializing its day time programmed parameters.When the physician interrogated the generator the most recent stimulation burst stored within its data was found to be 1.625ma.As the daytime settings was already initialized prior to a stimulation burst occurring with the daytime parameters, the disparity between the most recent stimulation burst of 1.625ma and the expected daytime settings of 1.5ma caused the high output current error message.Subsequent diagnostics were found to be within normal limits.No other relevant information has been received to date.
 
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Brand Name
PROGRAMMING SOFTWARE
Type of Device
PROGRAMMING 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
cindy scott
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key17927863
MDR Text Key325688541
Report Number1644487-2023-01461
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750443
UDI-Public05425025750443
Combination Product (y/n)N
Reporter Country CodeIS
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/18/2023
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 Model Number3000
Device Lot Number7060
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 09/20/2023
Initial Date FDA Received10/12/2023
Supplement Dates Manufacturer Received12/03/2023
Supplement Dates FDA Received12/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/17/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age16 YR
Patient SexMale
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