MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ACUITY Steerable; Implantable Lead

Model Number	4555
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	07/10/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that the patient had an ablation procedure for ventricular tachycardia (vt) on (b)(6) 2026.Subsequent to the ablation, on (b)(6) 2026, the patient was going in and out of slow vt; the cardiac resynchronization therapy defibrillator (crt-d) was set to 100 beats/minute in an effort to pace through the vt.Burst pacing was tried and the patient's arrhythmia accelerated, requiring a shock, which successfully converted.A lidocaine drip and propranolol were also administered.It was planned at the time to examine further medical management for the patient.The vt returned and it was observed that the left ventricular lead (lv) was inhibiting pacing.Technical services discussed that it was likely health-related.It was further reported that this patient passed away on (b)(6) 2026.The patient was to be cremated, and it was not stated whether the device system would be returned.Additional information is being requested.

• Brand Name: ACUITY Steerable
• 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; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50165505
• Report Number: 2124215-2026-42261
• Device Sequence Number: 12081960
• Product Code: NVY
• UDI-Device Identifier: 00802526419447
• UDI-Public: (01)00802526419447(17)150919
• Combination Product (Y/N): Y
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P050046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2026

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: 09/18/2015
• Device Model Number: 4555
• Device Catalogue Number: 4555
• Device Lot Number: 213067
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2026
• Initial Report FDA Received Date: 08/06/2026
• Date Device Manufactured: 09/18/2013
• 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; Required Intervention
• Patient Sex: Male