BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENTROX SL-S 65/16

    MDR report key: 1012593 · Received March 12, 2008

    Report

    Report Number
    1028232-2008-00344
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    January 4, 2008
    Report Date
    March 7, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P80023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS RETURNED FROM ELA WITH A COMPLAINT FORM. THIS LEAD WAS REMOVED DUE TO INFECTION. THERE ARE NO ADVERSE EVENTS REPORTED FOR THIS PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KENTROX SL-S 65/16 ICD LEAD LWS BIOTRONIK GMBH AND CO. 345988

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization