MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VIGILANT? EL ICD DR; Implantable Cardioverter Defibrillator (ICD)

Model Number	D233
Medical Device Problem Codes	Pacing Problem (1439); Defibrillation/Stimulation Problem (1573)
Health Effect - Clinical Code	Tachycardia (2095)
Date of Event	08/19/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered potential inappropriate therapy for an atrial tachycardia (at).Technical services (ts) reviewed stored episode and determined that the device delivered inappropriate anti-tachycardia pacing (atp) burst, the burst accelerated the ventricular rate into the ventricular tachycardia (vt) detection zone and became very stable, resulting in therapy delivery.Review of the stored electrograms (egms) suggested that the rhythm was atrial fibrillation (af) with rapid ventricular response (rvr).No additional adverse patient effects were reported.This icd remains in service.

• Brand Name: VIGILANT? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator (ICD)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; cashel road; clonmel E91 T 862; EI E91 T862
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50754168
• Report Number: 2124215-2026-48286
• Device Sequence Number: 9668538
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: (01)00802526587801(17)211126
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2026

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: Health Professional
• Device Expiration Date: 11/26/2021
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 575040
• 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: 08/24/2026
• Initial Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 12/11/2019
• 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