MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	A209
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	07/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had an inappropriate shock due to t-wave oversensing via reduced intrinsic amplitudes.The sensing vector was set to the secondary vector.Also, the device has reached end-of-life battery status and the clinic is wondering how long therapy will be available.Technical services reviewed the data and discussed the options.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; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22783539
• Report Number: 2124215-2025-56104
• Device Sequence Number: 18653321
• Product Code: LWS
• UDI-Device Identifier: 00802526544101
• UDI-Public: (01)00802526544101(17)170729
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/12/2025

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: 07/29/2017
• Device Model Number: A209
• Device Catalogue Number: A209
• Device Lot Number: 106616
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 08/12/2025
• Date Device Manufactured: 07/29/2015
• 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: 75 YR
• Patient Sex: Male