BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX SR 53

    MDR report key: 757051 · Received September 1, 2006

    Report

    Report Number
    1028232-2006-00187
    Event Type
    Injury
    Date Received
    September 1, 2006
    Report Date
    August 31, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS EXPLANTED BECAUSE OF AN INFECTION. POCKET AREA REVEALED A PUSTULE. THE LEADS WERE SENT TO THE HOSPITAL'S PATHOLOGY DEPARTMENT. OTHER PARTS TO THIS SYSTEM ARE: PHILOS II DR, MDR 1028232-06-0186, SELOX SR 45, MDR 1028232-06-0188.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX SR 53 PACER LEAD DTB BIOTRONIK GMBH AND CO. 343083 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization