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

Model Number	3501
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	09/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an additional inappropriate shock due to t-wave oversensing via wide intrinsic complexes.The sensing vector was set to the alternate vector.The office testing found poor sensing in all three of the sensing vectors.The doctor elected to program the therapy off and sent the patient home with a life vest.The plan is to explant and replace the system with a transvenous system.There were no additional adverse patient effects.The system remains implanted.

• Brand Name: EMBLEM? 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; 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: 50946052
• Report Number: 2124215-2026-51945
• Device Sequence Number: 10429557
• Product Code: LWS
• UDI-Device Identifier: 00802526599200
• UDI-Public: (01)00802526599200(17)220829
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/29/2022
• Device Model Number: 3501
• Device Catalogue Number: 3501
• Device Lot Number: 184198
• 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: 09/25/2026
• Initial Report FDA Received Date: 09/30/2026
• Date Device Manufactured: 08/29/2020
• 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: 63 YR
• Patient Sex: Male