MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EMBLEM? S-ICD Electrode Delivery System; Implantable Cardioverter Defibrillator (Non-Crt)

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	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after the implant procedure for this subcutaneous implantable cardioverter defibrillator (s-icd), it failed all sensing vectors due to the patients rhythm r-waves being too small.Previously the s-icd system had passed using the secondary sensing vector.Additionally, it was noted that during the implant procedure there two instances of tunneling with the tunneling tool.No further complications were observed due to the tunneling.Technical services (ts) was consulted and discussed troubleshooting options, with further examination recommended for the system sensing.A revision was performed the day after implant procedure since the implanted electrode migrated.No additional adverse patient effects were reported.

• Brand Name: EMBLEM? S-ICD Electrode Delivery System
• Common Device Name: Implantable Cardioverter Defibrillator (Non-Crt)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): Boston Scientific Corporation; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50691670
• Report Number: 2124215-2026-48137
• Device Sequence Number: 14931474
• Product Code: LWS
• UDI-Device Identifier: 00802526591907
• UDI-Public: (01)00802526591907(17)280229(10)38808316
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 4712
• Device Catalogue Number: 4712
• Device Lot Number: 38808316
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/09/2026
• Date Device Manufactured: 03/11/2026
• 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 Sex: Female