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

Model Number	4674
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	09/09/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient passed away on september 9th, 2026.During a routine cardiac resynchronization therapy defibrillator (crt-d) system implant, the patient experienced cardiac arrest.The cardiac arrest occurred while this left ventricular (lv) lead was being implanted and after the right ventricular (rv) lead was implanted.Backup pacing was provided on the rv lead.Cardiopulmonary resuscitation (cpr) was given to the patient, and the patient experienced ventricular tachycardia (vt) and ventricular fibrillation (vf) several times.The field representative noted the patient was stable after the procedure.It was later reported by the field representative that the patient passed away overnight.It was noted the crt-d was never implanted in the patient.This lv lead was an attempted implant.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: ACUITY? X4 Spiral S
• 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: 50950617
• Report Number: 2124215-2026-52087
• Device Sequence Number: 18516362
• Product Code: LWP
• UDI-Device Identifier: 00802526524554
• UDI-Public: (01)00802526524554(17)280228
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• 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
• Report Date (Section B): 09/30/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4674
• Device Catalogue Number: 4674
• Device Lot Number: 946469
• 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: 09/09/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 02/28/2026
• 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: Death
• Patient Age: 78 YR
• Patient Sex: Unknown