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

Model Number	D233
Medical Device Problem Codes	Pacing Problem (1439); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	08/27/2026
Type of Reportable Event	Serious Injury
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.
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) delivered an inappropriate burst of anti-tachycardia pacing (atp) and three inappropriate shocks.Technical services (ts) was consulted and agreed with the local field representative that the shocks were delivered for supraventricular tachycardia.Ts discussed proposed changes to the rate cutoff and discriminator changes in the ventricular tachycardia monitor only zone with the physician.No additional adverse patient effects were reported.This icd remains in service.

• Brand Name: VIGILANT? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator
• 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: 50883721
• Report Number: 2124215-2026-50885
• Device Sequence Number: 21499636
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: (01)00802526587801(17)261014
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/24/2026

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 Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 687681
• 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: 09/11/2026
• Initial Report FDA Received Date: 09/24/2026
• Date Device Manufactured: 11/05/2024
• 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: Other
• Patient Age: 42 YR
• Patient Sex: Male