BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THE Q-TRAK SUBCUTANEOUS ELECTRODE

    MDR report key: 22191742 · Received June 12, 2025

    Report

    Report Number
    2124215-2025-38675
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    May 15, 2025
    Report Date
    September 19, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    UDI-DI
    00802526563218
    PMA / PMN Number
    P110042/S000
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: CODE E060110 ADDED. FIELD H6.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED SEVERAL SHOCKS TO THE PATIENT DURING DIFFERENT ARRYTHMIAS, SOME APPROPRIATES AND OTHER INAPPROPRIATE DUE TO A NON-SUSTAINED RHYTHM AND OVERSENSING. SOME OF THE THERAPY SHOCKS WERE NOT EFFECTIVE TO DIVERT THE FAST VENTRICULAR RHYTHM BUT RATHER ACCELERATED TO VENTRICULAR FIBRILLATION (VF). THE SYSTEM EXHIBITED HIGH SHOCK IMPEDANCES OUT OF RANGE DUE TO THE PHYSIOLOGIC CHANGES OF THE PATIENT (LOSS AND GAIN OF WEIGHT). THE SYSTEM PLACEMENT WAS EVALUATED BY X-RAY AND THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE AND REPLACED IT WITH A TRANSVENOUS SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED SEVERAL SHOCKS TO THE PATIENT DURING DIFFERENT ARRYTHMIAS, SOME APPROPRIATES AND OTHER INAPPROPRIATE DUE TO A NON-SUSTAINED RHYTHM AND OVERSENSING. SOME OF THE THERAPY SHOCKS WERE NOT EFFECTIVE TO DIVERT THE FAST VENTRICULAR RHYTHM BUT RATHER ACCELERATED TO VENTRICULAR FIBRILLATION (VF). THE SYSTEM EXHIBITED HIGH SHOCK IMPEDANCES OUT OF RANGE DUE TO THE PHYSIOLOGIC CHANGES OF THE PATIENT (LOSS AND GAIN OF WEIGHT). THE SYSTEM PLACEMENT WAS EVALUATED BY X-RAY AND THE PHYSICIAN DECIDED TO EXPLANT THE DEVICE AND REPLACED IT WITH A TRANSVENOUS SYSTEM. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, THE SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM DELIVERED SEVERAL SHOCKS TO THE PATIENT DURING DIFFERENT ARRYTHMIAS, SOME APPROPRIATES AND OTHER INAPPROPRIATE DUE TO A NON-SUSTAINED RHYTHM AND OVERSENSING. SOME OF THE THERAPY SHOCKS WERE NOT EFFECTIVE TO DIVERT THE FAST VENTRICULAR RHYTHM BUT RATHER ACCELERATED TO VENTRICULAR FIBRILLATION (VF). THE SYSTEM EXHIBITED HIGH SHOCK IMPEDANCES OUT OF RANGE DUE TO THE PHYSIOLOGIC CHANGES OF THE PATIENT (LOSS AND GAIN OF WEIGHT). THE SYSTEM PLACEMENT IS GOING TO BE EVALUATE BY X-RAY AND THE PHYSICIAN IS GOING TO DECIDE ABOUT REPOSITION TO MAINTAIN LOWER IMPEDANCE AND A BETTER SHOCK VECTOR. THIS ELECTRODE REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UDI AND OTHER PRODUCT SPECIFIC INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2077768 THE Q-TRAK SUBCUTANEOUS ELECTRODE IMPLANTABLE ELECTRODE LWS BOSTON SCIENTIFIC CORPORATION 3400 A117694 00802526563218

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R