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	04/10/2026
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 presented to the emergency room (er).Upon review, it was noted that this s-icd system delivered an inappropriate electric shock due to oversensing and noise.Low amplitude was also noted.Isometric testing was performed and the noise was unable to reproduce.Further isometric testing and a chest x-ray were recommended to rule out lead integrity.The representative reprogrammed to pri and discharged the patient.Then, a revision procedure was performed and the s-icd system was explanted and replaced.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 (Section G): BOSTON SCIENTIFIC CORPORATION; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 25023057
• Report Number: 2124215-2026-22991
• Device Sequence Number: 18383526
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)171101
• 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
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2026

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: 11/01/2017
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A129092
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 07/01/2026
• 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: Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Sex: Male