BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 8294099 · Received January 31, 2019

    Report

    Report Number
    2649622-2019-01679
    Event Type
    Injury
    Date Received
    January 31, 2019
    Date of Event
    October 16, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MPRI
    Product Code
    LWS
    UDI-DI
    00643169356566
    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 JANUARY 31, 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 286, INCLUDING THE 3500A EVENT AND EVENTS DETAILED IN THE ATTACHED XLS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 744 REPORTED EVENTS. ALL EVENTS WERE REPORTED FOR INFECTION AND/OR EROSION. RANGE OF PATIENT AGE: 17-94 YEARS. RANGE OF PATIENT WEIGHT: 93-407 POUNDS. WHERE GENDER IS KNOWN, THE POPULATION INCLUDES: 26% FEMALE AND 74% MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87960 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62 00643169356566

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R