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

Model Number	4672
Medical Device Problem Codes	Failure to Capture (1081); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this left ventricular (lv) lead was explanted due to dislodgement confirmed through x-ray, resulting in loss of capture (loc) and a new lv lead of a different model was placed.This lead will be returned.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: 25213107
• Report Number: 2124215-2026-26864
• Device Sequence Number: 10473581
• Product Code: LWP
• UDI-Device Identifier: 00802526524530
• UDI-Public: (01)00802526524530(17)260508
• Combination Product (Y/N): Y
• Initial Reporter State: CO
• 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
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2026

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: 05/08/2026
• Device Model Number: 4672
• Device Catalogue Number: 4672
• Device Lot Number: 825048
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/05/2026
• 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: 04/27/2026
• Supplement Date Received by Manufacturer: 08/20/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 09/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• 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: 80 YR
• Patient Sex: Female