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

Model Number	3000
Medical Device Problem Codes	False Alarm (1013); Application Program Problem: Parameter Calculation Error (1449)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Medical professional reported that while reviewing programming session reports it was observed a patient had low output current.The patient generator was noted to have been disabled for surgery and re-programmed on for therapy.Low output current occurred when the patient was programmed back on.Medical professional was confirmed to be using (b)(4) software.Impedance was noted to be okay and battery status was 11-25%.Patient was not able to have system diagnostics re-performed prior to leaving office; however, no generator issues are suspected as this is a known event which can occur for (b)(4) software.Internal testing and data review identified that false low output current messages can occur when m3000 (b)(4) software programs a m103-106 generator after a specific programming sequence occurs.When m3000 (b)(4) tablets initiate a programming session with a m103-106 generator, where its output current is programmed off (0 ma), and then the output current is programmed back on to >0 ma, a low output current message would be seen when an in-session interrogation is performed.This would persist upon multiple in-session interrogations and if diagnostics weren't performed during the session, show on the session report.Running system diagnostics or ending and restarting the session will confirm functionality of the device, and resolve the ¿output current low¿ error message.The low output current messages in these cases are false and do not impact generator function.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.No further relevant information has been received to date.
Additional Manufacturer Narrative
H7.- correction - notification was not included in initial mdr.Voluntary medical device correction (remedial action) was initiated by the manufacturer on 2/4/2020, and the physician was provided a notification letter with recommended actions.H9.Internal reference number: (b)(4).

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING COMPUTER
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 11656365
• Report Number: 1644487-2021-00504
• Device Sequence Number: 3497613
• Product Code: LYJ
• UDI-Device Identifier: 05425025750535
• UDI-Public: 05425025750535
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse Practitioner
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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
• Operator of Device: Health Professional
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 03/19/2021
• Supplement Date Received by Manufacturer: 04/28/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 37 YR