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

Model Number	D233
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	08/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this implantable cardioverter defibrillator (icd) called in due to interrogation issues with the home monitor.Technical services (ts) reviewed and found there was a recent transmission with no noted episodes.The tele monitor displayed there was a failure to capture and the rate dropped below the lower rate limit into the 40s.The rate went back to the 60s.This icd remains in service.No adverse patient effects were reported.

• Brand Name: VIGILANT? EL ICD DR
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• 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: 50734245
• Report Number: 2124215-2026-48717
• Device Sequence Number: 21487772
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: (01)00802526587801(17)271028
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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 Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 719554
• 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: 08/12/2026
• Initial Report FDA Received Date: 09/11/2026
• Date Device Manufactured: 11/13/2025
• 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: 66 YR
• Patient Sex: Male