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

Model Number	4677
Medical Device Problem Codes	Difficult to Insert (1316); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this left ventricular (lv) lead was attempted due to unknown product performance reason.This lv lead was replaced and not implanted.No adverse patient effects were reported.
Event or Problem Description
It was reported that this left ventricular (lv) lead was attempted due to unknown product performance reason.This lv lead was replaced and not implanted.No adverse patient effects were reported.Additional information indicated that this lv lead could not be advanced into the vein, prompting selection of an alternative implant location.

• 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: 50189527
• Report Number: 2124215-2026-42557
• Device Sequence Number: 18644280
• Product Code: LWP
• UDI-Device Identifier: 00802526524592
• UDI-Public: (01)00802526524592(17)270609
• Combination Product (Y/N): Y
• Initial Reporter State: TX
• 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): 09/16/2026

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: Health Professional
• Device Model Number: 4677
• Device Catalogue Number: 4677
• Device Lot Number: 847671
• 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: 07/24/2026
• Supplement Date Received by Manufacturer: 08/30/2026
• Initial Report FDA Received Date: 08/10/2026
• Supplement Report FDA Received Date: 09/16/2026
• Date Device Manufactured: 06/09/2025
• 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: 82 YR
• Patient Sex: Female