BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE S

    MDR report key: 8025916 · Received October 31, 2018

    Report

    Report Number
    2649622-2018-17811
    Event Type
    Injury
    Date Received
    October 31, 2018
    Report Date
    October 31, 2018
    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

    FORM CODE: (B)(4). THESE EVENTS WERE REPORTED TO THE FDA ON OCTOBER 31, 2018 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 289. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [(B)(4)].

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 818 REPORTED EVENTS. ALL EVENTS WERE REPORTED FOR INFECTION AND/OR EROSION. RANGE OF PATIENT AGE: 14 TO 97 YEARS. RANGE OF PATIENT WEIGHT: 91-364 POUNDS. WHERE GENDER IS KNOWN, THE POPULATION INCLUDES 31% FEMALE AND 69% MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864329 SPRINT QUATTRO SECURE S DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62 00643169356566

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R