BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVEAL XT

    MDR report key: 3153635 · Received June 8, 2013

    Report

    Report Number
    9614453-2013-01149
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 29, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    DSI
    PMA / PMN Number
    K103764
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DECIDED TO HAVE THE DEVICE REMOVED DUE TO SCARS AND PAIN. IT WAS NOTED THAT THE PATIENT WAS ENROLLED IN THE INSIGHT XT STUDY. THE DEVICE WAS REMOVED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254377 REVEAL XT DETECTOR AND ALARM, ARRHYTHMIA DSI IPG MFG SWITZERLAND 9529

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R