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

Model Number	3000
Medical Device Problem Code	Computer Software Problem (1112)
Health Effect - Clinical Code	Seizures (2063)
Date of Event	01/19/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon interrogation it appeared that the patient's m102 had been reprogrammed to 30 to incorrect settings.The physician wanted to know why this event occurred and if it could have contributed to the patient's increased seizures.Review of the data found that an interrupted communication had led to faulted diagnostics on the patient's generator at the last appointment.M102 generators change settings from programmed settings to diagnostics settings back to programmed settings to run system diagnostics; therefore, when the diagnostics were interrupted, the settings were left at the diagnostics settings.The physician did not run a final interrogation as recommended per labeling so this settings change was not found and corrected until the next appointment.No further relevant information has been received to date.
Event or Problem Description
It was reported that the patient's increased seizure rate was worse than their pre-vns seizure rate.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: 8764707
• Report Number: 1644487-2019-01298
• Device Sequence Number: 13873016
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 08/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 3000
• Was Device Available for Evaluation?: No
• Event Location: Other
• Initial Date Received by Manufacturer: 06/12/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 07/05/2019
• Supplement Report FDA Received Date: 08/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 20 YR