BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 3991432 · Received August 8, 2014

    Report

    Report Number
    3004209178-2014-14289
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM COMPLAINING OF PAIN, TINGLING UP THE NECK AND SHOULDERS AND STRESS HEADACHES. THE SYMPTOMS WERE NOTED TO BE DUE TO THE IMPLANTABLE LOOP RECORDER (ILR) TRYING TO PUSH THROUGH THE SKIN WHICH WAS CAUSING NERVE DAMAGE. THE PATIENT WAS TREATED WITH MEDICATIONS FOR THE PAIN. ALL HEART TESTS WERE NORMAL SO THE DEVICE WAS SCHEDULED FOR EXPLANT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468915 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Hospitalization| R