BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 2851440 · Received October 31, 2012

    Report

    Report Number
    1028232-2012-02689
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    August 24, 2012
    Report Date
    October 4, 2012
    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

    THIS LEAD WAS CAPPED AND REPLACED DUE TO A "LEAD MALFUNCTION". ATTEMPTS TO GET ADDITIONAL INFORMATION REGARDING THE LEAD MALFUNCTION WERE NOT FRUITFUL. THERE WERE NO ADVERSE PT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE 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 86 YR Hospitalization