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

Model Number	3010
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	05/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered one shock as inappropriate therapy due t-wave oversensing.Technical services (ts) was consulted and discussed stored data as well as troubleshooting options.This device remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information regarding this event.At this time, no further information is available.Should additional information become available this report will be updated.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system delivered one shock as inappropriate therapy due t-wave oversensing.Technical services (ts) was consulted and discussed stored data as well as troubleshooting options.This device remains in service.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected fields: manufacturer name field (d3) in section d, suspect medical device.Model number field (d4) in section d, suspect medical device.Catalog number field (d4) in section d, suspect medical device.Mfr site address 1 field (g1) in section d, manufacturing site.Mfr site city field (g1) in section d, manufacturing site.Mfr site state field (g1) in section d, manufacturing site.Mfr site zip/post code field (g1) in section d, manufacturing site.A good faith effort was performed to obtain additional information regarding this event.At this time, no further information is available.Should additional information become available this report will be updated.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 4100 hamline ave n; saint paul MN 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22299033
• Report Number: 2124215-2025-40824
• Device Sequence Number: 9227718
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)161201(10)A116884
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 12/01/2016
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A116884
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/22/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 06/25/2025
• 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: 62 YR
• Patient Sex: Female