BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENTROX SL 65/16

    MDR report key: 756932 · Received August 30, 2006

    Report

    Report Number
    1028232-2006-00175
    Event Type
    Injury
    Date Received
    August 30, 2006
    Date of Event
    August 7, 2006
    Report Date
    August 22, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    PP980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DEVICE AND LEAD SYSTEM WERE EXPLANTED DUE TO INFECTION. NO REPLACEMENT SYSTEM IMPLANTED. THE SYSTEM WAS RETURNED. NON-COMPLIANT PT. HEAVY PHYSICAL ACTIVITY OCCURRED POST IMPLANT DISLODGING THE LEAD. THIS ALSO HAPPENED AFTER REPOSITIONING REQUIRING HOSPITALIZATION TO PREVENT ACTIVITY THAT DISLODGED THE LEAD. SECOND REPOSITIONING SUCCESSFUL, BUT INFECTION OCCURRED DUE TO MULTIPLE PROCEDURES. THIS IS PART OF A SYSTEM. SELOX JT-45, MDR 1028232-06-0176 AND LUMOS DR-T, MDR 1028232-06-0174.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization