MAUDE Adverse Event Report: LIVANOVA USA, INC. PULSE GEN MODEL 106; GENERATOR

Model Number	106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); Pneumonia (2011)
Date of Event	05/15/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a vns patient with severe epilepsy secondary to pitt-hopkins syndrome died on (b)(6) 2026 from aspiration-related lung disease/pneumonia.The patient had a long history of neurological impairment and chronic dysphagia that predated vns therapy.Vns therapy was initiated in 2017, with generator replacements in 2021 and (b)(6) 2026 due to normal battery depletion.Prior to the (b)(6) 2026 generator replacement, the generator had been inactive for approximately six months because of battery depletion.During this period, the patient's swallowing difficulties and coughing had already worsened.Settings were adjusted for dysphagia.In (b)(6) 2026, the patient developed severe aspiration-related pneumonia requiring icu admission and subsequently died.Although clinicians recommended temporarily suspending vns stimulation using the magnet to evaluate a possible relationship between stimulation and coughing, the family declined.The treating physician concluded that the patient's death was more likely related to progression of pre-existing dysphagia and aspiration risk, potentially exacerbated by intubation associated with the (b)(6) 2026 generator replacement procedure, rather than vns therapy itself.The death report identified aspiration pneumonia/lung disease as the cause of death and stated that the vns system was not believed to be related to the patient's death.No autopsy was performed, and no death certificate was provided.No other relevant information has been received to date.

• Brand Name: PULSE GEN MODEL 106
• Common Device Name: GENERATOR
• Manufacturer (Section D): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): LIVANOVA USA, INC.; 100 cyberonics boulevard; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; 2816672681
• MDR Report Key: 25861440
• Report Number: 1644487-2026-10861
• Device Sequence Number: 5266492
• Product Code: LYJ
• UDI-Device Identifier: 05425025750061
• UDI-Public: 05425025750061
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/17/2026

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: Lay User/Patient
• Device Model Number: 106
• Device Lot Number: 8223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/24/2026
• Initial Report FDA Received Date: 07/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/29/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Death
• Patient Age: 19 YR
• Patient Sex: Unknown