MAUDE Adverse Event Report: Oscor Inc EMBLEM S-ICD; Electrode

Model Number	3401
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) exhibited high out of range system impedance measurements.Technical services (ts) was consulted and reviewed stored data.Ts recommended further in clinic examination, with a revision possibly required.This device remains in service.No adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Common Device Name: 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: 50802552
• Report Number: 2124215-2026-49640
• Device Sequence Number: 16104676
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)180501
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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: 05/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A133206
• 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: 09/02/2026
• Supplement Date Received by Manufacturer: 09/24/2026
• Initial Report FDA Received Date: 09/17/2026
• Supplement Report FDA Received Date: 09/24/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male