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

Model Number	3400
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	04/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient had an inappropriate shock due to the oversensing of noise.A review of the electrograms found significant rail-to-rail noise.There were some stored untreated episodes due to the same railing noise.The sensing vector at the time of the shocks was set to the primary sensing vector.The noise started suddenly this past april.There were x-rays done which had shadowing which can be seen on the electrode and near the edge of the electrode body.The therapy is now programmed off.Technical services advised some programming options.The patient should come back for system programming.There were no additional adverse patient effects.The system remains implanted.

• 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: 25876946
• Report Number: 2124215-2026-38836
• Device Sequence Number: 10580249
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)170501(10)A121047
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2026

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 Expiration Date: 05/01/2017
• Device Model Number: 3400
• Device Catalogue Number: 3010
• Device Lot Number: A121047
• 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: 07/08/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2026
• Supplement Report FDA Received Date: 09/04/2026
• 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
• Patient Age: 57 YR
• Patient Sex: Male