MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE ELECTRODE

Model Number	3401
Medical Device Problem Codes	Signal Artifact/Noise (1036); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited mechanical noise on the presenting subcutaneous electrocardiogram (s-ecg) however, no inappropriate therapy occurred as a result.The patient was evaluated in clinic, and the noise was reproducible in both the secondary and alternate sensing vectors.A chest x-ray was performed, which identified a tight loop of the electrode in the pocket area.Based on these findings, there was suspicion of a lead fracture.The clinical plan was to either continue monitoring the device using the primary vector or proceed with lead replacement, at the discretion of the hospital.At this time, the lead remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Common Device Name: IMPLANTABLE ELECTRODE
• Manufacturer (Section D): OSCOR INC; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer (Section G): BOSTON SCIENTIFIC; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24845268
• Report Number: 2124215-2026-19561
• Device Sequence Number: 18376657
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190301
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2026

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: 03/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A145015
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: 05/06/2026; 05/27/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/06/2026; 06/08/2026
• Date Device Manufactured: 03/16/2017
• 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 Sex: Unknown