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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 3000
Device Problems False Alarm (1013); Application Program Problem: Parameter Calculation Error (1449)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2018
Event Type  malfunction  
Event Description
It was identified during a review of the programming history database for this generator that the patient's device showed a low output current on a faulted system diagnostic test.A diagnostic test was run the same day and it was seen the diagnostics were normal.Based on the information reviewed, it is suspected that the delay associated with the wand retries created an error in timing that prevented the normal expected delay between 'run' and 'highest_amp_delivered'.This is a known software defect that gives a false low output current if communication is disrupted during a system diagnostics being performed on a sentiva generator.No additional relevant information has been received to date.
 
Manufacturer Narrative
Corrected information, initial report: the report mentioned an event related to sentiva generator which is unrelated/irrelevant to this event.
 
Event Description
Data from the generator was reviewed and revealed that the device was at eos - pulse disabled upon interrogation.It is likely that the user re-enabled therapy, but due to the communication issues there was a problem with removing the pulse disabled byte.Thus when diagnostics were performed, it likely ran the test at 1ma as it does for disabled devices, however when comparing this to the programming value of 2.25ma, it triggered the low output warning.There is no indication of true low output current since the subsequent diagnostics showed ok output.Similar partial programming events have been previously investigated.If the partial programming event had changed output current, but the generator did not receive the startstim command before the programming event failed (telling it to start stimulation), a low output current message can be received if the user chooses to not retry the programming event and interrogates again before the off time expires.This is because the software is comparing the new programmed current value to measured delivered peak current and the pulse generator has not yet delivered the new current (which would update peak current to the new programmed current).No other relevant information has been received to date.
 
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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
MDR Report Key12285919
MDR Text Key265351081
Report Number1644487-2021-01077
Device Sequence Number1
Product Code LYJ
UDI-Device Identifier00542502575048
UDI-Public0542502575048
Combination Product (y/n)N
PMA/PMN Number
P970003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 10/01/2021
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 Lay User/Patient
Device Model Number3000
Was Device Available for Evaluation? No
Event Location Other
Initial Date Manufacturer Received 07/14/2021
Initial Date FDA Received08/06/2021
Supplement Dates Manufacturer Received09/08/2021
Supplement Dates FDA Received10/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age27 YR
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