BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2070311 · Received April 18, 2011

    Report

    Report Number
    1028232-2011-00858
    Event Type
    Injury
    Date Received
    April 18, 2011
    Date of Event
    March 15, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BOTH THE ATRIAL LEAD AND THE ASSOCIATED LV LEAD DISLODGED DUE TO TWIDDLER'S SYNDROME. THIS LEAD WAS SUCCESSFULLY REPOSITIONED ON (B)(6) 2011 AND ALL REPORTS INDICATE IT REMAINS ACTIVELY IMPLANTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization