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

Model Number	MODEL 3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Physician reported that the patient's device settings had changed without intentional programming by the physician.The physician altered the patient's duty cycle up towards rapid cycling, and did not change any output current.However, when device was checked again, the output current changed as well without physician intending this.
Additional Manufacturer Narrative
Unique identifier #, corrected data: initial report inadvertently listed "(b)(4)" instead of "(b)(4)".
Event or Problem Description
Additional investigation of this issue was performed via review of log files and it was revealed that this issue was due to a partial programming.During programming of new output currents, the output current is first cleared to 0 ma and then the new output current is programmed.However, due to disrupting in this programming process, the device output currents were cleared to 0 ma and the new output currents were not successfully programmed.Per labeling, if any parameter changes were made during a patient visit, it is recommended to perform a final interrogation prior to the end of the patient visit in order to confirm the generator is set to the desired values.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8011478
• Report Number: 1644487-2018-01938
• Device Sequence Number: 1435180
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2019

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: MODEL 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 10/01/2018
• Supplement Date Received by Manufacturer: 01/25/2019; 06/07/2019
• Initial Report FDA Received Date: 10/28/2018
• Supplement Report FDA Received Date: 01/28/2019; 06/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR