BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 2123809 · Received June 14, 2011

    Report

    Report Number
    6000144-2011-02383
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    December 17, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    DSI
    PMA / PMN Number
    K071641
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CALLED TO THE PHYSICIAN'S OFFICE REGARDING THEIR INSERTABLE CARDIAC MONITOR (ICM) WITH "FEELING OF PAIN AT THE INCISION SITE AND THAT THE DEVICE SEEMED TO BE COMING OUT." ALSO NOTED, WHEN SEEN IN THE PHYSICIAN'S OFFICE, THE INCISION SITE WAS INFECTED AND WAS "PROBABLY A REACTION TO THE MATERIAL." THE DEVICE WAS REMOVED. THERE WAS NO INFORMATION REGARDING ICM REPLACEMENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REVEAL XT IMPLANTABLE LOOP RECORDER DSI MEDTRONIC MED REL, INC. 9529 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| O| R