MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? MRI S-ICD; Subcutaneous implantable cardioverter defibrillator

Model Number	A219
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2026
Type of Reportable Event	Malfunction

• 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: 50086422
• Report Number: 2124215-2026-40945
• Device Sequence Number: 21400389
• Product Code: LWS
• UDI-Device Identifier: 00606959038219
• UDI-Public: (01)00802526584404(17)210903
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

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: 09/03/2021
• Device Model Number: A219
• Device Catalogue Number: A219
• Device Lot Number: 252992
• 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: 07/21/2026
• Supplement Date Received by Manufacturer: 09/03/2026; 09/24/2026
• Initial Report FDA Received Date: 07/30/2026
• Supplement Report FDA Received Date: 09/14/2026; 09/28/2026
• Date Device Manufactured: 09/25/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female