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

Model Number	3010
Medical Device Problem Codes	Signal Artifact/Noise (1036); Over-Sensing (1438)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this patient's subcutaneous implantable cardioverter defibrillator (s-icd) was turned off and electrode disconnected due to noise from the patient's left ventricular assist device (lvad).Per the field, the patient will be receiving a transvenous defibrillator in the upcoming months, and their s-icd system will be taken out at that time.For now, device therapy is off.No adverse patient effects were reported.
Event or Problem Description
It was reported that this patient's subcutaneous implantable cardioverter defibrillator (s-icd) was turned off and electrode disconnected due to noise from the patient's left ventricular assist device (lvad).Per the field, the patient will be receiving a transvenous defibrillator in the upcoming months, and their s-icd system will be taken out at that time.For now, device therapy is off.No adverse patient effects were reported.
Additional Manufacturer Narrative
Investigation summary: with all the available information, boston scientific concludes use error factors most probably contributed to the event.Device history record review: a device history record (dhr) review could not be performed as the required documentation was unavailable since the product was manufactured outside of boston scientific.If the applicable documentation becomes available, the investigation record will be re-opened and updated accordingly with the results of the device history record (dhr) review.Device technical analysis: this product remains implanted; therefore, technical analysis cannot be conducted.With all the available information, boston scientific concluses use error factors most likely contributed to the event as available information indciates the s-icd was turned off and the electrode disconnected due to the patient's lvad.Labeling review: review of labeling determined that the complaint situation was listed in the manual.The manual was unlikely to be the cause of the reported complaint; translation, wording, or graphics does not require further review.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of unintended use error caused or contributed to event.Risk assessment: a risk review was completed and confirmed that the event of oversensing was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.

• 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: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; +1(651)582-6168
• MDR Report Key: 25742898
• Report Number: 2124215-2026-36517
• Device Sequence Number: 13378723
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)161201(10)A116731
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2026

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: 12/01/2016
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A116731
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/07/2026
• Supplement Report FDA Received Date: 08/20/2026
• 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: Required Intervention
• Patient Age: 38 YR
• Patient Sex: Male