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

Model Number	3010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this electrode was explanted without a specific reason.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Corrected fields: describe event or problem field (b5) in section b, adverse event or product problem.
Event or Problem Description
It was reported that this electrode was explanted due to the patient suffering an infection.No additional adverse patient effects were reported.The device has been received and is pending analysis.
Additional Manufacturer Narrative
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 d, all manufacturers.Mfr site city field (g1) in section d, all manufacturers.Mfr site state field (g1) in section d, all manufacturers.Mfr site zip/post code field (g1) in section d, all manufacturers.Mfr site country field (g1) in section d, all manufacturers.Mfr site email field (g1) in section d, all manufacturers.
Event or Problem Description
It was reported that this electrode was explanted due to the patient suffering an infection.No additional adverse patient effects were reported.The device has been received and is pending analysis.
Additional Manufacturer Narrative
The returned electrode was thoroughly inspected and analyzed.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this electrode was explanted due to the patient suffering an infection.No additional adverse patient effects were reported.The device has been received and is pending analysis.The device has been analyzed.
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.The returned electrode was thoroughly inspected and analyzed.Laboratory analysis did not identify any electrode characteristics that would have caused or contributed to the reported clinical observations.
Event or Problem Description
It was reported that this electrode was explanted due to the patient suffering an infection.No additional adverse patient effects were reported.The device has been received and is pending analysis.The device has been analyzed.

• Brand Name: THE Q-TRAK SUBCUTANEOUS ELECTRODE
• Common Device Name: ELECTRODE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue n; 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: 22009623
• Report Number: 2124215-2025-30675
• Device Sequence Number: 5229133
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)170501(10)A121061
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P110042/S000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2025
• 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,Followup,Followup,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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 05/01/2017
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A121061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 05/14/2025; 05/19/2025; 06/12/2025; 06/22/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 05/14/2025; 05/19/2025; 06/16/2025; 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 60 YR
• Patient Sex: Female