MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; Subcutaneous Electrode

Model Number	3401
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Under-Sensing (1661)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	11/26/2025
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 the patient's subcutaneous implantable cardioverter defibrillator (s-icd) system delivered a treated shock.The recorded rhythm showed variable morphologies, raising uncertainty whether the episode represented atrial tachycardia with aberrant conduction or ventricular tachycardia.Following therapy, the rate remained elevated.Technical services noted occasional undersensing related to signal behavior and sensing profile characteristics.It remains unclear whether the shock was appropriate or inappropriate, and electrophysiology review is required to determine rhythm classification.The electrode remains in service.No adverse patient impact was reported.

• Brand Name: EMBLEM S-ICD
• Common Device Name: Subcutaneous Electrode
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): OSCOR INC; 3816 desoto blvd; palm harbor FL 34683
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25286199
• Report Number: 2124215-2026-28235
• Device Sequence Number: 10095170
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190201
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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,Followup,Followup
• Report Date (Section B): 10/02/2026

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: 02/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A143181
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/10/2026
• 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: 05/05/2026
• Supplement Date Received by Manufacturer: 07/22/2026; 08/10/2026; 09/30/2026
• Initial Report FDA Received Date: 05/26/2026
• Supplement Report FDA Received Date: 07/27/2026; 08/11/2026; 10/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2017
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male