BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 53

    MDR report key: 2851486 · Received October 31, 2012

    Report

    Report Number
    1028232-2012-02640
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Date of Event
    September 28, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BIOTRONIK SE AND 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 FRACTURE. THERE WAS LOSS OF CAPTURE AND IMPEDANCE READINGS GREATER THAN 3000. THERE WERE NO ADVERSE EVENTS REPORTED FOR THE PATIENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization