BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 8663850 · Received June 3, 2019

    Report

    Report Number
    2649622-2019-09468
    Event Type
    Malfunction
    Date Received
    June 3, 2019
    Date of Event
    November 16, 2018
    Report Date
    June 20, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00613994740915
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: DTBA1D1 CRT-D, IMPLANTED: (B)(6) 2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED OVERSENSING/NOISE DURING A STORED HIGH RATE NON-SUSTAINED EPISODE. THE RV LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT SUSPECTED ELECTROMAGNETIC INTERFERENCE CAUSED THE OVERSENSING/NOISE EPISODE, AND THE EPISODE WAS NOT RELATED TO AN RV LEAD ISSUE. THE ICD REMAINS IN USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457653 SPRINT QUATTRO SECURE MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694758 00613994740915

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 4469 LEAD, 419478 LEAD