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

Model Number	4678
Medical Device Problem Codes	Failure to Capture (1081); High Capture Threshold (3266)
Health Effect - Clinical Codes	Chest Pain (1776); Dyspnea (1816); Unspecified Heart Problem (4454); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk.This investigation will be updated should pertinent information become available in the future.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited intermittent loss of capture (loc) in the left ventricular (lv) lead.In addition, high threshold values were noted for both the lv and right ventricular (rv) leads.Technical services (ts) recommended reprogramming options.This left ventricular (lv) lead remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This report is being submitted to provide additional information on event description and coding.The device was not returned for analysis; therefore, a technical analysis could not be performed.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of known inherent risk.This investigation will be updated should pertinent information become available in the future.
Event or Problem Description
It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited intermittent loss of capture (loc) in the left ventricular (lv) lead.In addition, high threshold values were noted for both the lv and right ventricular (rv) leads.Technical services (ts) recommended reprogramming options.This left ventricular (lv) lead remains in service.No adverse patient effects were reported.Additional information was received.It was suspected that the loc was actually fusion beats.Additionally, it was mentioned that the patient experienced shortness of breath (sob), chest tightness and palpitations.Further clinical evaluation was recommended.This lv lead remains in service.No additional adverse patient effects were reported.

• 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: 24508300
• Report Number: 2124215-2026-12123
• Device Sequence Number: 21322159
• Product Code: LWP
• UDI-Device Identifier: 00802526524615
• UDI-Public: (01)00802526524615(17)200827
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 03/17/2026

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: 08/27/2020
• Device Model Number: 4678
• Device Catalogue Number: 4678
• Device Lot Number: 802303
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 03/04/2026
• Supplement Report FDA Received Date: 03/17/2026
• Date Device Manufactured: 08/27/2018
• 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: 74 YR
• Patient Sex: Female