BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROX RX 45-JBP

    MDR report key: 2082156 · Received April 29, 2011

    Report

    Report Number
    1028232-2011-00985
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    March 29, 2011
    Report Date
    April 18, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K981083
    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 LOSS OF CAPTURE. THE LEAD WAS REMOVED IN PIECES, SO IT WAS DISCARDED BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROX RX 45-JBP PACER LEAD DTB BIOTRONIK SE & CO. KG 124774

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization