BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 3861413 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-07273
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    March 23, 2014
    Report Date
    June 13, 2023
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00613994249876
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 419478 LEAD, IMPLANTED: (B)(6) 2007; D274TRK BIV ICD, IMPLANTED: (B)(6) 2010. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE AND THRESHOLD WERE ELEVATED. THE LEAD PROGRAMING WAS ADJUSTED AND THE RV 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
    338010 SPRINT QUATTRO SECURE MRI SURESCAN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MPRI 694758 00613994249876

    Patients

    Seq Age Sex Outcome Treatment
    1 00045 YR Male Required Intervention 5076-45, LEAD| 5076-45, LEAD