BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX JT 53

    MDR report key: 2082185 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00979
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    April 5, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    LOSS OF CAPTURE WAS NOTED ON THIS ATRIAL LEAD. DURING AN UPGRADE PROCEDURE TO AN ICD, THIS LEAD WAS SUCCESSFULLY REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX JT 53 PACER LEAD NVZ BIOTRONIK SE & CO. KG 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization