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

Model Number	D232
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the patient advocate that, after an ablation procedure, this implantable cardioverter defibrillator (icd) was turned off and likely not have been reenabled.Additionally, the patient advocate reported that the patient was in the emergency room waiting area.A boston scientific field clinical representative was paged, and the patient was referred to the managing physician for evaluation.To date, this icd remains in service.No adverse patient effects were reported.Additional information indicated that no patient injury or adverse clinical consequences occurred.No intervention was required, and the patient remained stable throughout the event.
Event or Problem Description
It was reported by the patient advocate that, after an ablation procedure, this implantable cardioverter defibrillator (icd) was turned off and likely not have been reenabled.Additionally, the patient advocate reported that the patient was in the emergency room waiting area.A boston scientific field clinical representative was paged, and the patient was referred to the managing physician for evaluation.To date, this icd remains in service.No adverse patient effects were reported.

• Brand Name: VIGILANT EL ICD VR
• 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: 50230549
• Report Number: 2124215-2026-43420
• Device Sequence Number: 16025306
• Product Code: LWS
• UDI-Device Identifier: 00802526587788
• UDI-Public: (01)00802526587788(17)220729
• Combination Product (Y/N): N
• 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: Consumer
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2026

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: 07/29/2022
• Device Model Number: D232
• Device Catalogue Number: D232
• Device Lot Number: 271947
• 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: 07/31/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/13/2026
• Supplement Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 08/06/2020
• 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: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male