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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); Low impedance (2285)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/17/2022
Event Type  malfunction  
Event Description
It was reported that when the patient was seen in clinic they presented with low impedance.The patient was then seen in clinic again and their lead impedance was found to be within normal limits.No other relevant information has been received to date.
 
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 livanova's 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
The patient was seen in clinic again and their impedance remains within normal limits.
 
Event Description
Internal testing and data review identified that false low output current messages can occur when the autostim threshold is changed during the 15 minute temporary test.Once the user programs on day/night settings, the programmer will instruct the ipg to start using night mode settings for the temporary (15 minute test).If any settings not related to stimulation parameters (current, on time, off time, etc) are changed, the programmer will command the ipg to stop the temporary test and the ipg will re-eneter day mode settings.When a system diagnostics is performed, the programmer errantly compares the diagnostics results (which were run with daytime stim parameters) against nighttime settings even though ipg is in day mode.Since night time stim (2.5ma) is higher than day time stim (2ma), this is interpreted as low output current.Based on the reported programming sequence that occurred that day, it was consistent with the false low output current mechanism described above.Therefore, the patient's generator is expected to be able to deliver therapy as programmed.
 
Event Description
Reviewing log files, it was found that during the programming event that occurred right after enabling day/night mode, the prone position detection was enabled and the low heart rate threshold was changed to 50 bpm.It is known that if any settings not related to stimulation parameters (current, on time, off time, etc) are changed, the programmer will command the ipg to stop the temporary test and the ipg will re-enter day mode settings.When a system diagnostics is performed, the programmer errantly compares the diagnostics results (which were run with daytime stim parameters) against nighttime settings even though ipg is in day mode.
 
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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
dana sprague
100 cyberonics blvd
suite 600
houston, TX 77058
2816672681
MDR Report Key15963529
MDR Text Key306089491
Report Number1644487-2022-01597
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier05425025750535
UDI-Public05425025750535
Combination Product (y/n)N
Reporter Country CodeBR
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,Followup,Followup
Report Date 06/14/2023
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 Lay User/Patient
Device Model Number3000
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Event Location Other
Initial Date Manufacturer Received 11/17/2022
Initial Date FDA Received12/12/2022
Supplement Dates Manufacturer Received01/16/2023
03/15/2023
06/12/2023
Supplement Dates FDA Received02/10/2023
04/10/2023
06/15/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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