MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? S-ICD Electrode Delivery System; Implantable Lead

Model Number	4712
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	07/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient with this device experienced an s-icd electrode delivery system (eds) perforation into the thoracic cavity during suprasternal tunneling.The eds was withdrawn, and the patient was monitored for bleeding, oxygen saturation, and vital signs, with no abnormalities noted.Tunneling was successfully performed again, and post-operative ultrasound and ct showed no abnormal findings.This sicd system remains in service.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: EMBLEM? S-ICD Electrode Delivery System
• Common Device Name: Implantable Lead
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50216503
• Report Number: 2124215-2026-43051
• Device Sequence Number: 20357961
• Product Code: LWS
• UDI-Device Identifier: 00802526591907
• UDI-Public: (01)00802526591907
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2026

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 Model Number: 4712
• Device Catalogue Number: 4712
• 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: 07/29/2026
• Supplement Date Received by Manufacturer: 09/29/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/30/2026
• 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: Other; Life Threatening; Required Intervention
• Patient Sex: Unknown