MAUDE Adverse Event Report: HOUSTON LEAD MODEL 303-20

Model Number	303
Medical Device Problem Codes	Therapy Delivered to Incorrect Body Area (1508); Migration (4003)
Health Effect - Clinical Codes	Neck Pain (2433); Shock from Patient Lead(s) (3162); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/20/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient came to the clinic complaining of discomfort during stimulation after making a sudden movement.An x-ray showed that the electrode had dislodged from the nerve.The patient has been referred to neurosurgery for review and to assess the possibility of reimplantation.No known relevant surgical intervention has occurred to date.No other relevant information has been received to date.

• Brand Name: LEAD MODEL 303-20
• Common Device Name: LEAD
• Manufacturer (Section D): HOUSTON; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer (Section G): HOUSTON; 100 cyberonics boulevard; suite 600; houston TX 77058
• Manufacturer Contact: cindy scott ; 100 cyberonics boulevard; suite 600; houston, TX 77058 ; 2816672681
• MDR Report Key: 25186771
• Report Number: 1644487-2026-10596
• Device Sequence Number: 10702709
• Product Code: LYJ
• UDI-Device Identifier: 05425025750115
• UDI-Public: 05425025750115
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P970003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/07/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/04/2026
• Device Model Number: 303
• Device Lot Number: 7129
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 06/30/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/17/2026; 07/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2022
• 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: Other
• Patient Sex: Unknown