BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 60

    MDR report key: 2111776 · Received May 25, 2011

    Report

    Report Number
    1028232-2011-01173
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 6, 2011
    Report Date
    May 18, 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

    THIS LEAD WAS EXPLANTED AND REPLACED DUE TO DISLODGEMENT. IT WAS DISCARDED BY THE HOSP AND WILL NOT BE RETURNED. SHOULD ADD'L INFO BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 60 PACER LEAD NVZ BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization