BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 2964780 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02306
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    November 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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. CONCOMITANT PRODUCTS: 5592 IMPLANTABLE PACING LEAD: (B)(6) 2010. 5076 IMPLANTABLE PACING LEAD: (B)(6) 2010. (B)(4). -

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISCOMFORT DUE TO THE IMPLANTABLE CARDIAC MONITOR SO IT WAS REMOVED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68944 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI MEDTRONIC MED REL MEDTRONIC PUERTO RICO 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00033 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR (IPG)