BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLYROX PX 45-JPB

    MDR report key: 2215018 · Received August 12, 2011

    Report

    Report Number
    1028232-2011-01827
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    July 27, 2011
    Report Date
    August 2, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD DISLODGED DURING A BYPASS SURGERY. A REPOSITIONING PROCEDURE WAS ATTEMPTED, BUT CAPTURE COULD NOT BE OBTAINED AND A NEW LEAD WAS IMPLANTED INSTEAD. THE HOSPITAL HAS RETAINED THIS LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLYROX PX 45-JPB PACER LEAD DTB BIOTRONIK SE & CO. KG 120435

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization