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

Model Number	MODEL 250
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Software version: 11.0.4.
Event or Problem Description
It was reported that the patient came in for her device to be disabled for an mri scan.The patient's settings had been set to 0 ma and then the generator was reinterrogated and the settings were verified.No diagnostics were performed that day.Then the patient was interrogated at the next appointment and found to be at "factory settings" - 1 ma output current.Reportedly the last diagnostics was prior to the disablement of the device.Therefore it was not possible that a faulted diagnostics caused the factory default settings.The territory representative indicated that this office often incorrectly used equipment.No further relevant information has been received to date.
Event or Problem Description
It was reported that the device remained disabled after being reset.No further relevant information has been received to date.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 8032473
• Report Number: 1644487-2018-01969
• Device Sequence Number: 1379554
• Product Code: LYJ
• UDI-Device Identifier: 05425025750375
• UDI-Public: 05425025750375
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: MODEL 250
• Event Location: Other
• Initial Date Received by Manufacturer: 10/08/2018
• Supplement Date Received by Manufacturer: 02/05/2021
• Initial Report FDA Received Date: 11/02/2018
• Supplement Report FDA Received Date: 03/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR