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

Model Number	3401
Medical Device Problem Codes	Defibrillation/Stimulation Problem (1573); Under-Sensing (1661); Low impedance (2285)
Health Effect - Clinical Code	Device Overstimulation of Tissue (1991)
Date of Event	01/12/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this electrode exhibited low out of range shock impedance measurements of 18 ohms.The patient reported feeling a shocking sensation when the impedance is measured.After a shock delivery there was flatline and there were questions if the device had delivered the shock, the alternate sensing vectors was noted to be flatline with mostly undersensing of qrs complexes.This electrode was explanted and successfully replaced.No additional adverse patient effects were reported.
Event or Problem Description
It was reported that this electrode exhibited low out of range shock impedance measurements of 18 ohms.The patient reported feeling a shocking sensation when the impedance is measured.After a shock delivery there was flatline and there were questions if the device had delivered the shock, the alternate sensing vectors was noted to be flatline with mostly undersensing of qrs complexes.This electrode was explanted and successfully replaced.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
This product remains in service and has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.It was confirmed that this device met manufacturing specifications prior to distribution and there was no indication that the device manufacturing process contributed to the reported complaint.A risk review was completed and confirmed that the event of shock impedance low out of range was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Based on a thorough review of the reported complaint, the conclusion code known inherent risk of device.

• 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: 24222684
• Report Number: 2124215-2026-05540
• Device Sequence Number: 8085542
• Product Code: LWS
• UDI-Device Identifier: 00802526575600
• UDI-Public: (01)00802526575600(17)180801
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2026
• 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,Followup
• Report Date (Section B): 03/31/2026

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: 08/01/2018
• Device Model Number: 3401
• Device Catalogue Number: 3401
• Device Lot Number: A135810
• 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: 01/12/2026
• Supplement Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 03/31/2026
• 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: 67 YR
• Patient Sex: Male