BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE S MRI SURESCAN

    MDR report key: 8709776 · Received June 18, 2019

    Report

    Report Number
    2649622-2019-10449
    Event Type
    Malfunction
    Date Received
    June 18, 2019
    Date of Event
    May 28, 2019
    Report Date
    June 18, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169356566
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: 5076-45 LEAD, IMPLANTED: (B)(6) 2017; 29-US TRANSCATHETER VALVE, IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SPOUSE CALLED AND REPORTED THAT THE PATIENT'S DEVICE IS "MAKING NOISES EVERY FOUR HOURS" AND WANTED TO KNOW IF IT WAS AN EMERGENCY. THE SPOUSE WAS INSTRUCTED ON HOW TO HOOK UP THE MONITOR AND SENT A REMOTE TRANSMISSION. THE TRANSMISSION INDICATED AN ALERT FOR LOW PACING IMPEDANCE READINGS ON THE RIGHT VENTRICULAR LEAD. THE PATIENT WAS ENCOURAGED TO CONTINUE TO TRY MAKING CONTACT WITH THE PATIENT'S PHYSICIAN TO DISCUSS THIS. THE RIGHT VENTRICULAR LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    501830 SPRINT QUATTRO SECURE S MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62 00643169356566

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR