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

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.

• Brand Name: PROGRAMMING SOFTWARE
• Type of Device: PROGRAMMING COMPUTER
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 12285919
• MDR Text Key: 265351081
• Report Number: 1644487-2021-01077
• Device Sequence Number: 1
• Product Code: LYJ
• UDI-Device Identifier: 00542502575048
• UDI-Public: 0542502575048
• Combination Product (y/n): N
• PMA/PMN Number: P970003
• Number of Events Reported: 1
• 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 Number: 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/08/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 27 YR