MAUDE Adverse Event Report: HOUSTON MODEL 3000; PROGRAMMING SOFTWARE

Model Number	3000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Livanova usa, inc.Submits this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation, based on information that livanova has obtained, but may not have been able to investigate or verify prior to the date the report was required by the fda.This report does not constitute an admission, or a conclusion by fda or anyone else, that the device, livanova, or livanova's employees caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any "defects¿ or "malfunctions¿.These words are incorporated into the fda 3500a medwatch form by the fda, and livanova objects to their use.
Event or Problem Description
It was reported by the physician that it was believed that the patient's autostim events were not being detected.The sensitivity of the heart rate detection was increased to 3 then later to 4 with no events seen after (b)(6) 2025.It was reported that magnet events were also not being seen under events.Tablet data was requested and a decoder was performed: no anomalies were identified during the review.All values were found to be within normal limits and no anomalies were noted.The total magnet swipes and auto stimulations can be seen to have increased between the last two interrogations, confirming that both features are working.Later, it was reported that this patient's generator was replaced due to "autostim issue", which is considered to be an unanticipated surgical intervention for the patient.The generator has not been returned to date.No other relevant information has been received to date.
Event or Problem Description
Additional internal review of tablet data was performed.No failure was able to be identified.It was speculated that one potential root cause for heartbeat/seizure undersensing/detection is an asic (a2) or capacitor component failure.This cannot be confirmed to date.No other relevant information has been received to date.
Event or Problem Description
Analysis of the generator was conducted in which no anomalies were located.

• Brand Name: MODEL 3000
• Common Device Name: PROGRAMMING SOFTWARE
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 23097592
• Report Number: 1644487-2025-10631
• Device Sequence Number: 18478436
• Product Code: LYJ
• UDI-Device Identifier: 05425025750443
• UDI-Public: 05425025750443
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/27/2026

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?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2025
• Supplement Date Received by Manufacturer: 09/22/2025; 01/02/2026
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 10/17/2025; 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR
• Patient Sex: Male