MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	3401
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	12/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this leadless pacemaker and subcutaneous implantable cardioverter defibrillator exhibited an inappropriate electric shock due to oversensing.Upon review, it was noted slow ventricular tachycardia (vt), which changed the amplitude.Oversensing led to inappropriate electric shock.Currently, this product remains in service and no additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 23770130
• Report Number: 2124215-2025-90176
• Device Sequence Number: 15890429
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190501
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2026

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: 05/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A146821
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 08/27/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 09/14/2026
• Date Device Manufactured: 05/19/2017
• 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: 65 YR
• Patient Sex: Male