BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 1982281 · Received February 1, 2011

    Report

    Report Number
    1028232-2011-00246
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 21, 2011
    Manufacturer
    BIORONIK 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

    THIS LEAD WAS REMOVED DUE TO DISLODGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization