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); Inappropriate/Inadequate Shock/Stimulation (1574); Failure to Read Input Signal (1581); Impedance Problem (2950)
Health Effect - Clinical Code	Shock from Patient Lead(s) (3162)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this patient with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock due to what appeared to be noise and t wave oversensing with a very small signal.The smartpass feature of the s-icd was disabled.Technical services (ts) discussed turning sp back on and attempting another vector.Noise could not be recreated in clinic, and the system impedance was low.It was questioned whether the s-icd had migrated, which the field representative noted it did seem to be a bit anterior.Ts recommended x ray imaging.Automatic setup was unsuccessful in the current vector of secondary, so primary was reprogrammed with much larger qrs complexes.The physician was considering defibrillation threshold (dft) test and revision, however ts requested x rays first until there is more information.There was no dft at the original implant.An untreated event was observed with small and wider qrs complexes, so it was questioned if this patient has any fluid buildup or rate dependent bundle.The physician was going to evaluate this patient for heart failure and possible fluid.This electrode remains in service currently.No adverse patient effects were reported.
Additional Manufacturer Narrative
If pertinent information is provided in the future, a supplemental report will be submitted.
Additional Manufacturer Narrative
Correction to d4 model number from 3400 to 3010.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this patient with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock due to what appeared to be noise and t wave oversensing with a very small signal.The smartpass feature of the s-icd was disabled.Technical services (ts) discussed turning sp back on and attempting another vector.Noise could not be recreated in clinic, and the system impedance was low.It was questioned whether the s-icd had migrated, which the field representative noted it did seem to be a bit anterior.Ts recommended x ray imaging.Automatic setup was unsuccessful in the current vector of secondary, so primary was reprogrammed with much larger qrs complexes.The physician was considering defibrillation threshold (dft) test and revision, however ts requested x rays first until there is more information.There was no dft at the original implant.An untreated event was observed with small and wider qrs complexes, so it was questioned if this patient has any fluid buildup or rate dependent bundle.The physician was going to evaluate this patient for heart failure and possible fluid.This electrode remains in service currently.No adverse patient effects were reported.
Additional Manufacturer Narrative
Correction to d4 model number from 3400 to 3010.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this patient with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock due to what appeared to be noise and t wave oversensing with a very small signal.The smartpass feature of the s-icd was disabled.Technical services (ts) discussed turning sp back on and attempting another vector.Noise could not be recreated in clinic, and the system impedance was low.It was questioned whether the s-icd had migrated, which the field representative noted it did seem to be a bit anterior.Ts recommended x ray imaging.Automatic setup was unsuccessful in the current vector of secondary, so primary was reprogrammed with much larger qrs complexes.The physician was considering defibrillation threshold (dft) test and revision, however ts requested x rays first until there is more information.There was no dft at the original implant.An untreated event was observed with small and wider qrs complexes, so it was questioned if this patient has any fluid buildup or rate dependent bundle.The physician was going to evaluate this patient for heart failure and possible fluid.This electrode remains in service currently.No adverse patient effects were reported.Additional information was received that this patient had lost a considerable amount of weight.This patient will continue to be monitored.
Additional Manufacturer Narrative
Correction to d4 model number from 3400 to 3010.If pertinent information is provided in the future, a supplemental report will be submitted.
Event or Problem Description
It was reported that this patient with this subcutaneous implantable cardioverter defibrillator (s-icd) system received an inappropriate shock due to what appeared to be noise and t wave oversensing with a very small signal.The smartpass feature of the s-icd was disabled.Technical services (ts) discussed turning sp back on and attempting another vector.Noise could not be recreated in clinic, and the system impedance was low.It was questioned whether the s-icd had migrated, which the field representative noted it did seem to be a bit anterior.Ts recommended x ray imaging.Automatic setup was unsuccessful in the current vector of secondary, so primary was reprogrammed with much larger qrs complexes.The physician was considering defibrillation threshold (dft) test and revision, however ts requested x rays first until there is more information.There was no dft at the original implant.An untreated event was observed with small and wider qrs complexes, so it was questioned if this patient has any fluid buildup or rate dependent bundle.The physician was going to evaluate this patient for heart failure and possible fluid.This electrode remains in service currently.No adverse patient effects were reported.Additional information was received that this patient had lost a considerable amount of weight.This patient will continue to be monitored.

• 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 ; 6515826168
• MDR Report Key: 23906567
• Report Number: 2124215-2025-93386
• Device Sequence Number: 21315313
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)170501(10)A120893
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 01/12/2026

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: A120893
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 01/07/2026; 01/12/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 01/05/2026; 01/09/2026; 01/12/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Male