BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 53

    MDR report key: 2140327 · Received June 17, 2011

    Report

    Report Number
    1028232-2011-01341
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 9, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P980037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO A POSSIBLE LEAD FRACTURE AND HAS BEEN RETAINED BY THE HOSPITAL. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 53 PACING LEAD NVZ BIOTRONIK SE & CO. KG 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization