BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 3152516 · Received June 7, 2013

    Report

    Report Number
    3004209178-2013-09027
    Event Type
    Injury
    Date Received
    June 7, 2013
    Date of Event
    March 6, 2013
    Report Date
    April 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION AT THE DEVICE SITE. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND THE DEVICE REMAINS IN USE. THE PATIENT IS A PARTICIPANT IN THE MONITORING IN (B)(4) CLINICAL STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253077 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention