MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION The Q-TRAK Subcutaneous Electrode; Implantable Cardioverter Defibrillator (Non-Crt)

Model Number	3400
Medical Device Problem Codes	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	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a review for a possible atrial fibrillation (af) episode was requested for this subcutaneous implantable cardioverter defibrillator (s-icd) system.Technical services (ts) was consulted and discussed stored data.Ts noted this s-icd system had its smart pass feature disabled due to the patients poor morphology.This device remains in service.No adverse patient effects were reported.At a later date, the patient with this s-icd system had an arrhythmia for which appropriate therapy was delivered but oversensing was noted during the episode.Additionally, another shock was delivered as inappropriate therapy due to oversensing of the patients signals, with poor morphology noted for the patients rhythm.Technical services (ts) was consulted and discussed stored data as well as the device programmed settings.This device remains in service.No additional adverse patient effects were reported.

• Brand Name: The Q-TRAK Subcutaneous Electrode
• 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; 229 avenida fabricante; san clemente CA 92672
• Manufacturer Contact: mark mischke ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(612)875-7234
• MDR Report Key: 25749409
• Report Number: 2124215-2026-36572
• Device Sequence Number: 16013135
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)161101(10)A116306
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/28/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/01/2016
• Device Model Number: 3400
• Device Catalogue Number: 3400
• Device Lot Number: A116306
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2026
• Supplement Date Received by Manufacturer: 07/12/2026; 09/24/2026
• Initial Report FDA Received Date: 07/08/2026
• Supplement Report FDA Received Date: 07/13/2026; 09/28/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male