MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number	3401
Medical Device Problem Codes	High impedance (1291); Over-Sensing (1438); Failure to Convert Rhythm (1540)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had an untreated episode stored due to t-wave oversensing.The sensing vector was set to the secondary vector.Later, during a tachycardia episode, the device had difficulty converting the arrhythmia.The arrhythmia self-converted.Also, the high energy shock impedance was 100 ohms, which is high but within normal limits.An x-ray was done and technical services advised some testing and programming options.There were no additional adverse patient effects.The system remains implanted.

• 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): OSCOR, INCORPORATED; 3816 desoto blvd.; palm harbor FL 34683
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24850634
• Report Number: 2124215-2026-19680
• Device Sequence Number: 5624087
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)180401
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/28/2026

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: 04/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A132347
• 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: 03/23/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 04/11/2026
• Supplement Report FDA Received Date: 05/28/2026
• 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
• Patient Age: 73 YR
• Patient Sex: Male