BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 11844588 · Received May 18, 2021

    Report

    Report Number
    2649622-2021-09937
    Event Type
    Death
    Date Received
    May 18, 2021
    Date of Event
    April 23, 2021
    Report Date
    May 18, 2021
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00613994249890
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 439688, LEAD, IMPLANTED: (B)(6) 2015. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD TRIGGERED A LEAD INTEGRITY ALERT (LIA) DUE TO NON-SUSTAINED VENTRICULAR TACHYCARDIA AND SENSING INTEGRITY COUNTER (SIC). THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION (VF) AND THE RV LEAD EXHIBITED UNDERSENSING AFTER HIGH VOLTAGE THERAPY WAS PROVIDED. THE VENTRICULAR FIBRILLATION (VF) EPISODE WAS NOTED TO BE TERMINATED. NON-SUSTAINED VENTRICULAR TACHYCARDIA EPISODES WERE DETECTED, HOWEVER, THE PATIENT WAS IN A VENTRICULAR FIBRILLATION (VF) ARRHYTHMIA AT THE TIME AND THE DEVICE WAS UNABLE TO APPROPRIATELY DETECT OR DELIVER THERAPY. IT WAS LATER CONFIRMED THAT THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737901 SPRINT QUATTRO SECURE MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765 00613994249890

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death DTMA1D1 CRTD, 383069 LEAD