BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENTROX SL 65/16

    MDR report key: 814254 · Received February 6, 2007

    Report

    Report Number
    1028232-2007-00028
    Event Type
    Injury
    Date Received
    February 6, 2007
    Date of Event
    September 25, 2006
    Report Date
    January 31, 2007
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    LWS
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED DUE TO INFECTION. ALSO INCLUDED WITH THIS SYSTEM IS A LUMOS VR-T, MDR 1028232-07-0027.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO 347351 *

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization