BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE MRI SURESCAN

    MDR report key: 8641310 · Received May 24, 2019

    Report

    Report Number
    2649622-2019-08987
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    May 24, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00613994740922
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THESE EVENTS WERE REPORTED TO THE FDA ON APRIL 30, 2019 FOR THE ALTERNATIVE SUMMARY REPORTING FOR INFECTION AND/OR EROSION WITH FDA APPROVAL NUMBER E1997002. FOR ALL PRODUCTS RETURNED TO THE MANUFACTURER AND ANALYZED, NO PERFORMANCE ISSUES WERE IDENTIFIED. THE TOTAL NUMBER OF EVENTS BEING SUMMARIZED FOR PRODUCT CODE LWS IS 86, INCLUDING THE 3500A EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 174 REPORTED EVENTS. ALL EVENTS WERE REPORTED FOR INFECTION AND/OR EROSION. RANGE OF PATIENT AGE: (B)(6) - (B)(6). RANGE OF PATIENT WEIGHT: (B)(6) - (B)(6). WHERE GENDER IS KNOWN, THE POPULATION INCLUDES 23% FEMALE AND 77% MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435065 SPRINT QUATTRO SECURE MRI SURESCAN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 694765 00613994740922

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R