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

Model Number	4677
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) and this left ventricular (lv) lead exhibited a loss of capture.There was a high capture threshold on this lv lead.Technical services (ts) recommended in clinic threshold testing.This lv lead remains in service.No adverse patient effects were reported.Additional information was received.It was reported that the health care professional (hcp) planned to do an lv lead revision.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: 50360096
• Report Number: 2124215-2026-45054
• Device Sequence Number: 12271936
• Product Code: LWP
• UDI-Device Identifier: 00802526524592
• UDI-Public: (01)00802526524592(17)190710
• 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: 2018
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2026

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: 07/10/2019
• Device Model Number: 4677
• Device Catalogue Number: 4677
• Device Lot Number: 802753
• 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/04/2026
• Date Device Manufactured: 01/10/2018
• 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: 29 YR
• Patient Sex: Male