MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY? X4 SPIRAL L; IMPLANTABLE LEAD

Model Number	4677
Medical Device Problem Codes	Failure to Capture (1081); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cardiac resynchronization therapy defibrillator (crt-d) exhibited a loss of capture on this left ventricular (lv) lead.The patient was seen in office on (b)(6) 2026, and the threshold was in range at that time.Technical services (ts) reviewed the presenting electrogram (egm) and observed varying morphologies.Ts suspected there may be a positional component effecting threshold value.Ts recommended further evaluation in clinic.This lv lead remains in service.No 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.If pertinent information is provided in the future, a supplemental report will be submitted.

• 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; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25256635
• Report Number: 2124215-2026-27704
• Device Sequence Number: 5418337
• Product Code: LWP
• UDI-Device Identifier: 00802526524592
• UDI-Public: (01)00802526524592(17)200616
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P010012
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2026

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 Expiration Date: 06/16/2020
• Device Model Number: 4677
• Device Catalogue Number: 4677
• Device Lot Number: 805113
• 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: 04/30/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 07/09/2026
• Initial Report FDA Received Date: 05/22/2026
• Supplement Report FDA Received Date: 05/28/2026; 07/10/2026
• Date Device Manufactured: 06/16/2018
• 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
• Patient Age: 77 YR
• Patient Sex: Male