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

Model Number	4675
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Hematoma (1884); Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this brady lead stated experiencing pain and bleeding during recovery post device implant or pocket closure.The patient was returned to the cardiac catheterization laboratory, where an incision was made and the existing device pocket was reopened.This brady lead was disconnected from the device, bleeding was controlled, and the pocket was flushed with an antibiotic solution.This lead was then placed into an antibacterial envelope and repositioned into the pocket, with immediate pacing and sensing confirmed.The pocket was subsequently closed, and the patient was transferred back to recovery in stable condition.To date, this brady lead was explanted.No additional adverse patient effects were reported.

• Brand Name: ACUITY X4 SPIRAL S
• 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: 25055220
• Report Number: 2124215-2026-23720
• Device Sequence Number: 13086482
• Product Code: LWP
• UDI-Device Identifier: 00802526524578
• UDI-Public: (01)00802526524578(17)260405
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026

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: 04/05/2026
• Device Model Number: 4675
• Device Catalogue Number: 4675
• Device Lot Number: 831697
• 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: 04/15/2026
• Supplement Date Received by Manufacturer: 06/17/2026
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 07/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/05/2024
• 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: 70 YR
• Patient Sex: Male