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

Model Number	3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/12/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after programming patient for guided mode and setting the patient on step 2, the set values of the normal stimulation, magnet mode and autostim did not line up with the custom protocol step values for stimulation.No further relevant information has been received to date.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
Further review of data shows that the programmer was successful in creating the protocol and initiating steps 1 and 2 of that protocol which matches the piexport.The values seen on session report and shown in piexport are no backed up by logged files.There was no interrogation or information shown that would transpire between the ipg and programmer that would cause the incorrect normal output current value.If this device were to be interrogated again, the correct values should still be programmed and it was the programmer that caused values to be displayed.Around the time of step 2 of the protocol being implemented there were a lot of communication errors.Incorrectly seen on session report were likely caused by communication errors seen and perhaps some default values seen in the programmer background.
Additional Manufacturer Narrative
B5.Event description - correction - inadvertently piexport review was not added in previous supplemental mdr submitted.H6.Results code - correction inadvertently no listed in previous supplemental mdr submitted.

• Brand Name: PROGRAMMING SOFTWARE
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics blvd; houston TX 77058
• MDR Report Key: 9928350
• Report Number: 1644487-2020-00543
• Device Sequence Number: 14102345
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2020

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
• Event Location: Other
• Initial Date Received by Manufacturer: 03/12/2020
• Supplement Date Received by Manufacturer: 04/27/2020; 06/01/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 04/27/2020; 06/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1