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

Model Number	D233
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this implantable cardioverter defibrillator (icd) exhibited t wave oversensing that resulted in one burst of inappropriate anti-tachycardia pacing (atp).Ts was consulted and confirmed the inappropriate therapy was not exhausted; however, the patient was hospitalized during this time.Ts noted the r wave amplitude had previously decreased by remained normal.Ts discussed reprogramming options but did not conclude on the best option.Ts recommended a chest x ray to review system positioning.No additional adverse patient effects were reported.This icd remains in service.
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.

• 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: 50666608
• Report Number: 2124215-2026-47736
• Device Sequence Number: 18680295
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: 01/08/2025
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 636534
• 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: 09/08/2026
• Date Device Manufactured: 01/17/2023
• 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: Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male