BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC REVEAL XT

    MDR report key: 2792461 · Received October 10, 2012

    Report

    Report Number
    MW5027239
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    September 13, 2012
    Report Date
    October 10, 2012
    Manufacturer
    MEDTRONIC INC
    Product Code
    DXE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS AT AIMMC ON (B)(6) 2012 FOR EVENT MONITOR IMPLANT, F/U IN DEVICE CLINIC FOR POST OP WOUND CHECK ON (B)(6) 2012 WITH NO PROBLEMS NOTED. PT RETURNED TO DEVICE CLINIC (B)(6) 2012 WITH C/O PAIN AND YELLOWISH DRAINAGE AT DEVICE SITE, GIVEN PO ANTIBIOTICS, CBC AND WOUND CULTURES DONE. PT RETURNED TO EP LAB (B)(6) 2012 FOR EXPLANTS OF EVENT MONITOR DUE TO INFECTION IN AT DEVICE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC REVEAL XT MONITOR IMPLANT DXE MEDTRONIC INC 9529 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention