BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROX RX 45 - JBP

    MDR report key: 2190109 · Received June 30, 2011

    Report

    Report Number
    1028232-2011-01499
    Event Type
    Malfunction
    Date Received
    June 30, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 21, 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 CAPPED DUE TO HIGH THRESHOLDS.

    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 60 YR Hospitalization