MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION The Q-TRAK Subcutaneous Electrode; Implantable Lead

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	05/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this electrode received an inappropriate therapy.Smart pass became disabled.Review determined that one treated episode was appropriate for a true arrhythmia, while another was inappropriate due to oversensing of low-amplitude, wide signals.The device was reprogrammed to the secondary 2x sensing vector with smart pass re-enabled, and additional programming changes were considered to reduce future inappropriate therapy.The electro remains in service.No adverse patient effects were reported.
Additional Manufacturer Narrative
This product investigation is still in progress.This report will be updated when product investigation is complete.

• Brand Name: The Q-TRAK Subcutaneous Electrode
• Common Device Name: Implantable Lead
• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25728154
• Report Number: 2124215-2026-36213
• Device Sequence Number: 10645104
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)161101(10)A116306
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2026

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?: No
• 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: Not provided
• Initial Report FDA Received Date: 07/06/2026
• Supplement Report FDA Received Date: 08/20/2026
• 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
• Patient Age: 83 YR
• Patient Sex: Male