MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? MRI S-ICD; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	A219
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	04/26/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had inappropriate shocks due to t-wave oversensing via reduced intrinsic complexes.The smart pass feature had programmed itself off due to the low intrinsic amplitudes.The sensing vector was programmed to the primary vector.Office testing found the sensing was poor in all three of the sensing vectors.The xrays were done and are unchanged from implant.The electrode is a bit left of the sternum to avoid the sternal wires.Technical services advised some testing options.There were no additional adverse patient effects.The system remains implanted.

• Brand Name: EMBLEM? MRI S-ICD
• 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: 50948567
• Report Number: 2124215-2026-52031
• Device Sequence Number: 15827507
• Product Code: LWS
• UDI-Device Identifier: 00802526584404
• UDI-Public: (01)00802526584404(17)280105
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 348266
• 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: 09/22/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 01/21/2026
• 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: Other
• Patient Age: 44 YR
• Patient Sex: Male