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	07/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the last clinic visit, the patient's settings were noted to have reset to default settings.Since the last visit, the patient began having worsening seizures and is now having drops in seizures, more frequent/longer daytime seizures and nightly nocturnal seizures.The patient's settings were able to be titrated back up close to what they previously were.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 when they were found to have reset.No additional relevant information has been received to date.
Event or Problem Description
It was reported by the physician that the patient had improved seizure control with vns, however when the device underwent unintended adjustments to the settings, this temporarily correlated with the dramatic decline in seizure control for the patient.The patient went from having a few seizures a month to increased daily seizures with increased intensity.The increased seizure frequency and intensity lead to falls and injuries which had not been occurring before.Seizures were also noted to cluster at night more often than before.The patient has had over a dozen falls in 6 months that the settings were changed, when she had no seizure related falls before.The family failed to report the decline in seizure control, therefore the patient's device was not interrogated, and the patient could not report events since they are intellectually challenged.The physician indicated that they were unaware what faulted diagnostics were until after this took place.No additional 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: 11147484
• Report Number: 1644487-2021-00053
• Device Sequence Number: 14326253
• Product Code: LYJ
• UDI-Device Identifier: 05425025750481
• UDI-Public: 05425025750481
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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
• Report Date (Section B): 02/04/2021

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: 12/17/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 02/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1