MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? X4 Straight; Implantable Lead

Model Number	4672
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that the patient with this cardiac resynchronization therapy pacemaker (crt-p) system underwent a tricuspid valve replacement.It was unknown if the leads contributed to the tricuspid valve needing replacement.During the procedure, the right ventricular (rv) lead, the non-boston scientific right atrial (ra) lead and this left ventricular (lv) lead were cut at the superior vena cava (svc) junction and surgically abandoned.A portion of the lv lead remained in the coronary sinus.It was noted that the crt-p remained implanted in the patient, and a leadless pacemaker was also implanted.The crt-p was reprogrammed due to the leads being surgically abandoned.After the procedure, an alert was observed for low out of range impedance on the ra lead and high out of range pacing impedance on the rv and lv lead.However, these alerts were due to the leads being surgically abandoned.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; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25460174
• Report Number: 2124215-2026-30958
• Device Sequence Number: 12938777
• Product Code: LWP
• UDI-Device Identifier: 00802526524530
• UDI-Public: (01)00802526524530(17)230315
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/20/2026

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: 03/15/2023
• Device Model Number: 4672
• Device Catalogue Number: 4672
• Device Lot Number: 812799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: Not provided; 08/25/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 08/20/2026; 09/10/2026
• Date Device Manufactured: 03/15/2021
• 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: 62 YR
• Patient Sex: Male