MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY X4 STRAIGHT; IMPLANTABLE LEAD

Model Number	4672
Medical Device Problem Code	High Capture Threshold (3266)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	04/28/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this left ventricular (lv) lead experienced a diaphragmatic stimulation upon routine interrogation.The available vectors were reviewed and noted that there was no acceptable combination of a good pacing threshold and low diaphragmatic stimulation threshold.This lv lead was explanted, replaced with different model and was disposed.No additional adverse patient effects were reported.

• Brand Name: ACUITY X4 STRAIGHT
• Common Device Name: IMPLANTABLE LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25161384
• Report Number: 2124215-2026-25816
• Device Sequence Number: 8661042
• Product Code: LWP
• UDI-Device Identifier: 00802526524530
• UDI-Public: (01)00802526524530(17)271211
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/13/2026

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 Model Number: 4672
• Device Catalogue Number: 4672
• Device Lot Number: 831348
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2026
• Initial Report FDA Received Date: 05/13/2026
• Date Device Manufactured: 12/11/2025
• 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; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male