BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS MRI SURESCAN

    MDR report key: 8641326 · Received May 24, 2019

    Report

    Report Number
    2649622-2019-08988
    Event Type
    Injury
    Date Received
    May 24, 2019
    Report Date
    May 24, 2019
    Manufacturer
    MPRI
    Product Code
    DTB
    UDI-DI
    00643169708198
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THESE EVENTS WERE REPORTED TO THE FDA ON MAY 24, 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 DTB IS 88, INCLUDING THE 3500A EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 174 REPORTED EVENTS. ALL EVENTS WERE REPORTED FOR INFECTION AND/OR EROSION. RANGE OF PATIENT AGE: 29 YEARS- 92 YEARS. RANGE OF PATIENT WEIGHT: 143-400 POUNDS. WHERE GENDER IS KNOWN, THE POPULATION INCLUDES 23% FEMALE AND 77% MALE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    432925 CAPSUREFIX NOVUS MRI SURESCAN ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 407652 00643169708198

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R