MAUDE Adverse Event Report: OSCOR INC EMBLEM S-ICD; Implantable Lead

Model Number	3401
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	04/19/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The local area field representative was contacted for additional information regarding event resolution.At this time, no further information is available.Should additional information become available this report will be updated.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 this subcutaneous implantable cardioverter defibrillator (s-icd) and electrode delivered inappropriate shocks due to double- and triple-counting.Surface echocardiogram (s-ecg) review of one treated episode had showed p-wave oversensing, and the morphology did not change post-shock.It was noted that this s-icd was programmed to secondary, 1x gain, and the r-waves were wide and biphasic in the presenting/captured s-ecg.In primary and alternate, the r-waves were narrow.Technical services (ts) recommended considering primary.This electrode remains in service.No additional adverse patient effects were reported.

• Brand Name: EMBLEM S-ICD
• Common Device Name: Implantable Lead
• 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: 25644747
• Report Number: 2124215-2026-34382
• Device Sequence Number: 18601514
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)170601
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/13/2026

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: 06/01/2017
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A122528
• Was Device Available for Evaluation?: No
• 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: 06/01/2026
• Supplement Date Received by Manufacturer: 08/11/2026
• Initial Report FDA Received Date: 06/27/2026
• Supplement Report FDA Received Date: 08/13/2026
• 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: 57 YR
• Patient Sex: Male