MAUDE Adverse Event Report: Houston Pulse Gen Model 1000; Generator

Model Number	1000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Movement Disorder (4412)
Date of Event	08/16/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient presented with a new onset of "choreiform-type movement disorder" two days after a vns battery replacement.Brain mri and csf were reportedly unremarkable.Normal and autostim output currents were turned off.Update was later received that the event was more aligned with the movement disorder, ballismus.The vns was disabled for several hours to assess whether the stimulation was contributing to the patient's symptoms.Despite cessation of stimulation, no improvement or reduction in the choreiform/ballistic movements was observed update was later received that the patient passed away.The patient died due to worsening hypoxaemic respiratory failure from aspiration pneumonia.It was noted by the treating team that the medications administered in an attempt to control the severe movement disorder may have increased the patient's respiratory vulnerability.Additionally, while the patient had a known history of kbg syndrome, the underlying condition was not considered sufficient to explain the abrupt onset and severity of the neurological symptoms.As such, clinicians indicated that the movement disorder itself, and/or complications associated with its treatment, may have contributed to the patient's overall clinical deterioration and subsequent death.No other relevant information has been received to date.

• Brand Name: Pulse Gen Model 1000
• Common Device Name: Generator
• Manufacturer (Section D): Houston; 100 cyberonics boulevard; houston TX 77058
• Manufacturer (Section G): Houston; 100 cyberonics boulevard; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics blvd; houston, TX 77058 ; +1(281)667-2681
• MDR Report Key: 50860474
• Report Number: 1644487-2026-11115
• Device Sequence Number: 10053822
• Product Code: LYJ
• UDI-Device Identifier: 05425025750405
• UDI-Public: 05425025750405
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse Practitioner
• Type of Report: Initial
• Report Date (Section B): 09/22/2026

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: 1000
• Device Lot Number: 206787
• 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: 09/01/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/05/2026
• 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: Death; Hospitalization
• Patient Age: 8 YR
• Patient Sex: Male