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); Impedance Problem (2950)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited high out of range system impedance measurements.X-ray imaging were performed.Technical services (ts) was consulted and reviewed stored data as well as x-ray images.X-ray images did not show any issues.A revision was performed and some damage was observed on the electrode when examined.There were difficulties removing the electrode, so it was damaged during the process.The s-icd system was explanted.A new device was implanted.No additional adverse patient effects were reported.This product has not been returned for 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.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited high out of range system impedance measurements.X-ray imaging were performed.Technical services (ts) was consulted and reviewed stored data as well as x-ray images.X-ray images did not show any issues.A revision was performed and some damage was observed on the electrode when examined.There were difficulties removing the electrode, so it was damaged during the process.The s-icd system was explanted.A new device was implanted.No additional adverse patient effects were reported.This product has not been returned for analysis.
Additional Manufacturer Narrative
Model number field (d4) in section d, suspect medical device.Catalog number field (d4) in section d, suspect medical device.This report is being filed due to an update with the evaluation method, results and conclusion codes.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited high out of range system impedance measurements.X-ray imaging were performed.Technical services (ts) was consulted and reviewed stored data as well as x-ray images.X-ray images did not show any issues.A revision was performed and some damage was observed on the electrode when examined.There were difficulties removing the electrode, so it was damaged during the process.The s-icd system was explanted.A new device was implanted.No additional adverse patient effects were reported.This product has not been returned for analysis.
Event or Problem Description
It was reported that this subcutaneous implantable cardioverter defibrillator (s-icd) system exhibited high out of range system impedance measurements.X-ray imaging were performed.Technical services (ts) was consulted and reviewed stored data as well as x-ray images.X-ray images did not show any issues.A revision was performed and some damage was observed on the electrode when examined.There were difficulties removing the electrode, so it was damaged during the process.The s-icd system was explanted.A new device was implanted.No additional adverse patient effects were reported.This product has not been returned for 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.This report is being filed due to an update with the evaluation method, results and conclusion codes.Corrected fields: 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.

• 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 avenue north; saint paul CA 55112
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 22079505
• Report Number: 2124215-2025-33575
• Device Sequence Number: 18318475
• Product Code: LWS
• UDI-Device Identifier: 00802526563201
• UDI-Public: (01)00802526563201(17)160801(10)A114700
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/04/2025

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: 08/01/2016
• Device Model Number: 3010
• Device Catalogue Number: 3010
• Device Lot Number: A114700
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 05/25/2025; 07/25/2025; 08/03/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 05/26/2025; 07/28/2025; 08/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Male