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

Model Number	3010
Medical Device Problem Codes	Difficult to Remove (1528); Defective Device (2588)
Health Effect - Clinical Codes	Erosion (1750); Unspecified Infection (1930)
Date of Event	07/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.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 the patient with this electrode had an erosion and infection.This electrode was surgically abandoned due to a product performance issue.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.At this time, no further information is available.Should additional information become available this report will be updated.Corrected fields: 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 g, all manufacturers.Mfr site city field (g1) in section g, all manufacturers.Mfr site zip/post code field (g1) in section g, all manufacturers.
Event or Problem Description
It was reported that the patient with this electrode had an erosion and infection.This electrode was surgically abandoned due to a product performance issue.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
A good faith effort was performed to obtain additional information.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 the patient with this electrode had an erosion and infection.This electrode was surgically abandoned due to a product performance issue.No additional adverse patient effects were reported.Additional information from the field indicates this electrode was unable to be extracted, so it was capped and surgically abandoned.No additional adverse patient effects were reported.

• 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: 22680508
• Report Number: 2124215-2025-53103
• Device Sequence Number: 9447872
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)160901(10)A115303
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2025

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: 09/01/2016
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A115303
• 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: 07/02/2025
• Supplement Date Received by Manufacturer: 08/03/2025; 08/12/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 08/04/2025; 08/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Female