MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? MRI S-ICD; Subcutaneous Implantable Cardioverter Defibrillator

Model Number	A219
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Under-Sensing (1661)
Health Effect - Clinical Code	Syncope/Fainting (4411)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited a delay in shock therapy due to functional undersensing.Early in the patient's ventricular arrythmia episode, there were large, polymorphic ventricular tachycardia (vt) and ventricular fibrillation (vf) amplitudes that slowed the device's ability to increase its sensitivity.Then, this s-icd sensed the vf and provided appropriate shock therapy.Technical services (ts) suspected therapy was delayed by two to three seconds.Ts discussed a vector change would not resolve this issue.Also, the patient reported syncope during this episode.This s-icd remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: EMBLEM? MRI S-ICD
• Common Device Name: Subcutaneous 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: 50946690
• Report Number: 2124215-2026-51959
• Device Sequence Number: 15859147
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: (01)00802526584404(17)260415
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

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 Expiration Date: 04/15/2026
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 308522
• 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: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 04/19/2024
• 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
• Patient Age: 39 YR
• Patient Sex: Female