MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? S-ICD; Subcutaneous Electrode

Model Number	3501
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917)
Health Effect - Clinical Codes	Dizziness (2194); Shock from Patient Lead(s) (3162)
Date of Event	01/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered an inappropriate shock due to oversensing of noise.The patient reported feeling dizzy before the shock episode.It was noted the patient has a left ventricular assist device (lvad).Technical services (ts) reviewed device data and suspected the noise was non-physiological.Ts recommended troubleshooting options.The field representative confirmed no noise was reproducible with xyphoid palpitations, pocket manipulation, or isometrics.Ts suspected sense b noise.Ts discussed due to the lvad, secondary vector wasn't an option.Ts recommended other reprogramming options or replacing the entire system.However, ts discussed that sense b could occur again on a new system.The field representative stated they would discuss the options with electrophysiology (ep).It was noted the patient was also on the transplant list.Currently, this electrode remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM? S-ICD
• Common Device Name: Subcutaneous Electrode
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; road 698, lot no. 12; dorado PR 00646 -260; PR 00646-2602
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50946999
• Report Number: 2124215-2026-51975
• Device Sequence Number: 9499245
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: (01)00802526599200(17)210807
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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: 08/07/2021
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 163283
• 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: 09/19/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 08/07/2019
• 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: 44 YR
• Patient Sex: Male