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

Model Number	3010
Medical Device Problem Codes	Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Shock from Patient Lead(s) (3162); Unspecified Mental, Emotional or Behavioural Problem (4430)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient with this leadless pacemaker and subcutaneous implantable cardioverter defibrillator system aborted anti-tachycardia pacing (atp) due to inappropriate sensing of non-physiological signals.As the atp was not delivered it was determined that they would continue to monitor and check in at the next scheduled appointment with device interrogation.Additional information received indicates that this s-icd system exhibited oversensing, leading to inappropriate electric shock.Currently, this s-icd system remains in service and no additional adverse patient effects were reported.
Event or Problem Description
It was reported that the patient with this leadless pacemaker and subcutaneous implantable cardioverter defibrillator system aborted anti-tachycardia pacing (atp) due to inappropriate sensing of non-physiological signals.As the atp was not delivered it was determined that they would continue to monitor and check in at the next scheduled appointment with device interrogation.Additional information received indicates that this s-icd system exhibited oversensing, leading to inappropriate electric shock.It was noted that the inappropriate shock caused emotional and mental distress.Currently, this s-icd system remains in service and no additional 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: 21527964
• Report Number: 2124215-2025-13659
• Device Sequence Number: 15881040
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: 00802526563201
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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
• Report Date (Section B): 03/18/2025

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: 05/01/2017
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A121149
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/05/2025
• Supplement Report FDA Received Date: 03/18/2025
• 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: 43 YR
• Patient Sex: Male