BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 15754308 · Received November 8, 2022

    Report

    Report Number
    2649622-2022-22521
    Event Type
    Malfunction
    Date Received
    November 8, 2022
    Date of Event
    August 16, 2022
    Report Date
    November 8, 2022
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: DTMA1D1 ICD; IMPLANTED: (B)(6) 2022. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD DISPLAYED UNDEFINED HIGH SUPERIOR VENA CAVA (SVC) COIL IMPEDANCE. IT WAS NOTED THAT THE FRACTURED SUPERIOR VENA CAVA (SVC) COIL EXISTED BEFORE THE RECENT GENERATOR CHANGE. THE 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
    2529726 SPRINT QUATTRO SECURE MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 694765

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Male 5076-52 LEAD, 419388 LEAD