BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PHILOS DR

    MDR report key: 788922 · Received November 29, 2006

    Report

    Report Number
    1028232-2006-00262
    Event Type
    Injury
    Date Received
    November 29, 2006
    Date of Event
    October 2, 2006
    Report Date
    November 21, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS OUS LEAD WAS EXPLANTED DUE TO EROSION AND INFECTION. YP 53, SN: MDR 1028232-06-0264. TIR 53, SN: MDR 1028232-06-0263.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PHILOS DR PACEMAKER DTB BIOTRONIK GMBH AND CO. 331443 *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization