BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLROX PX 45 JBP

    MDR report key: 1071011 · Received July 2, 2008

    Report

    Report Number
    1028232-2008-00713
    Event Type
    Malfunction
    Date Received
    July 2, 2008
    Date of Event
    April 25, 2008
    Report Date
    June 5, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.,
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS LEAD WAS CAPPED DUE TO CHRONIC HIGH THRESHOLDS. PER MARK WEBER, THE PHYSICIAN COULD NOT REPOSITION THIS LEAD. THIS LEAD WAS REPLACED WITH SELOX JT 45.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLROX PX 45 JBP PACER LEAD DTB BIOTRONIK GMBH AND CO., 120435

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization