MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? X4 Spiral L; Implantable lead

Model Number	4678
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this left ventricular (lv) lead was suspected to have exhibited loss of capture.Technical services (ts) was consulted to review the presenting electrogram, in which ts agreed a deflection on the lv was late, making it difficult to confirm loss of capture.Ts noted the system was recently implanted and had few daily measurements; however, measurements from a left ventricular automatic threshold test also exhibited possible loss of capture.Ts recommended to evaluate the lead in clinic and suggested x rays of the system.No adverse patient effects were reported.This lv lead remains in service.

• Brand Name: ACUITY? X4 Spiral L
• 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: 25680076
• Report Number: 2124215-2026-35155
• Device Sequence Number: 18569208
• Product Code: LWP
• UDI-Device Identifier: 00802526524615
• UDI-Public: (01)00802526524615(17)270805
• Combination Product (Y/N): Y
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 816953
• 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: 06/09/2026
• Supplement Date Received by Manufacturer: 09/14/2026
• Initial Report FDA Received Date: 07/01/2026
• Supplement Report FDA Received Date: 09/15/2026
• Date Device Manufactured: 08/05/2025
• 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
• Patient Age: 47 YR
• Patient Sex: Male