MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION THE Q-TRAK SUBCUTANEOUS ELECTRODE; IMPLANTABLE ELECTRODE

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	12/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered an inappropriate electric shock due to oversensing.It was also noted that the smart pass feature was disabled prior this shock per health care professional (hcp).Technical services (ts) reviewed and noted af/flutter episodes during sleep, qrs changes from 2mv to 1.2mv with wider complexes, and patient now in flutter/fib.Smart pass was re-enabled, stable r-wave observed in sleeping position.Plan is cardioversion next week, if amplitude returns to 2mv.At this time this product remains in service and no 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.With the available information, boston scientific concluded the clinical observation of oversensing is a known inherent risk of the product and is noted within the instructions for use (ifu), as well as the product's risk documentation.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.This device remains in service.As such, physical analysis has not been conducted in our laboratory.However, a labeling review and risk review were conducted.These reviews determined that the clinical observation of oversensing is a known inherent risk of the product.Review of labeling determined that the complaint situation was listed in the manual.There was no indication in the complaint that the product was not used in accordance with labeling.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.This oversensing has been observed with this product previously and is a known inherent risk associated with its use and is documented in the labeling of this product.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered an inappropriate electric shock due to oversensing.It was also noted that the smart pass feature was disabled prior this shock per health care professional (hcp).Technical services (ts) reviewed and noted af/flutter episodes during sleep, qrs changes from 2mv to 1.2mv with wider complexes, and patient now in flutter/fib.Smart pass was re-enabled, stable r-wave observed in sleeping position.Plan is cardioversion next week, if amplitude returns to 2mv.At this time this product remains in service and no adverse patient effects were reported.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Common Device Name: IMPLANTABLE ELECTRODE
• 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 ; 6515826168
• MDR Report Key: 24201795
• Report Number: 2124215-2026-05054
• Device Sequence Number: 5509196
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)161101(10)A116648
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• 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): 03/20/2026

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: Health Professional
• Device Expiration Date: 11/01/2016
• Device Model Number: 3400
• Device Catalogue Number: 3400
• Device Lot Number: A116648
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 01/28/2026
• Supplement Report FDA Received Date: 03/20/2026
• 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: 57 YR
• Patient Sex: Male