BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEXTRUS 4137

    MDR report key: 2232538 · Received August 19, 2011

    Report

    Report Number
    1028232-2011-01916
    Event Type
    Injury
    Date Received
    August 19, 2011
    Date of Event
    June 24, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    OUS MDR.

    Description of Event or Problem · 1

    OUS MDR - BOSTON SCIENTIFIC RECEIVED INFO THAT THE PT WITH THIS SYSTEM EXPERIENCED ITCHING AND A WART WAS OBSERVED AROUND THE DEVICE POCKET AREA. THE PACEMAKER, RA AND RV LEADS WERE EXPLANTED. IMPLANT AND EXPLANT DATES WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEXTRUS 4137 PACER LEAD NVZ BIOTRONIK SE & CO. KG 360314

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization