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

Model Number	3401
Medical Device Problem Codes	High impedance (1291); Failure to Read Input Signal (1581); Unexpected Therapeutic Results (1631); Under-Sensing (1661)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this subcutaneous implantable cardioverter defibrillator (s-icd) system received therapy for a ventricular arrhythmia that required two shocks for successful conversion.Review of the episode noted that the first shock was unsuccessful and undersensing of the low-amplitude ventricular fibrillation (vf) resulted in delayed detection.Shock impedance during the episode was 114 ohms, while measured system impedance was 75 ohms; this difference is considered expected due to normal variations.The device was programmed to the secondary sensing vector and smart pass enabled.The device remains in service.No adverse patient effects were reported.Additional information obtained, this subcutaneous implantable cardioverter defibrillator (s-icd) system has been explanted and replaced.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: EMBLEM S-ICD
• Common Device Name: Electrode
• Manufacturer (Section D): Oscor Inc; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 50056041
• Report Number: 2124215-2026-40297
• Device Sequence Number: 13418869
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)180401
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Company Representative
• Type of Report: Initial
• Report Date (Section B): 07/28/2026

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: 04/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A132398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Initial Report FDA Received Date: 07/28/2026
• 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: 52 YR
• Patient Sex: Male