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

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	10/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited oversensing of noisy signals and t-waves.Technical services (ts) was consulted and reviewed stored data.Ts recommended further in clinic examination and x-ray imaging to determine possible repositioning.This device remains in service.No adverse patient effects were reported.At a later date, this s-icd system delivered two shocks as inappropriate therapy due t-wave oversensing.This device remains in service.No additional 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 24986207
• Report Number: 2124215-2026-22363
• Device Sequence Number: 16080813
• Product Code: LWS
• UDI-Device Identifier: 00802526585968
• UDI-Public: (01)00802526585968(17)190501
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/24/2026

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: 05/01/2019
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A146891
• 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: 04/20/2026
• Initial Report FDA Received Date: 04/24/2026
• Date Device Manufactured: 05/19/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 52 YR
• Patient Sex: Female