BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELOX P 53-BP

    MDR report key: 2121456 · Received May 6, 2011

    Report

    Report Number
    1028232-2011-01044
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K994240
    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 INCONSISTENT THRESHOLD READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELOX P 53-BP PACER LEAD DTB BIOTRONIK SE & CO. KG 342306

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization