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

Model Number	3501
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Malposition of Device (2616)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	09/10/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system was unable to induce an arrythmia at implant.Imaging was completed, and it appeared the s-icd system was too superior but was unable to be confirmed by the imaging performed at that time.After being discharged after implant, the patient experienced two inappropriate shocks and presented to the emergency room (er).In the er, the patient's device therapy was programmed off.Technical services (ts) reviewed the two shock episodes.The first shock episode was caused by small amplitudes and oversensing of noisy signals.The second episode was caused by small amplitudes and t-wave oversensing.There was no change in rhythm after shock therapy.Ts recommended performing further imaging to confirm system location and determine if a system revision was required.This electrode remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.This product investigation is still in progress.This report will be updated when product investigation is complete.

• 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: 50898179
• Report Number: 2124215-2026-51198
• Device Sequence Number: 13439744
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: (01)00802526599200(17)280629
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 364532
• 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: 09/15/2026
• Initial Report FDA Received Date: 09/25/2026
• Date Device Manufactured: 06/30/2026
• 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: Required Intervention
• Patient Age: 54 YR
• Patient Sex: Unknown