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

Model Number	D233
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	09/05/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient, implanted with this implantable cardioverter defibrillator (icd) system, had passed out over the weekend.The patient was brought in for an office visit, where it was confirmed the patient had a syncopal episode that correlated with her ventricular fibrillation (vf) episode.The device operated appropriately and converted the rhythm to normal sinus rhythm.This icd system remains in service, and no programming changes were needed.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.\ \ this product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: 50830961
• Report Number: 2124215-2026-50083
• Device Sequence Number: 15965257
• Product Code: LWS
• UDI-Device Identifier: 00802526587801
• UDI-Public: (01)00802526587801(17)230715
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: P960040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2026

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: 07/15/2023
• Device Model Number: D233
• Device Catalogue Number: D233
• Device Lot Number: 604823
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/18/2026
• Date Device Manufactured: 07/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Unknown