BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KENTROX SL 65/16

    MDR report key: 1032064 · Received April 21, 2008

    Report

    Report Number
    1028232-2008-00384
    Event Type
    Injury
    Date Received
    April 21, 2008
    Date of Event
    March 13, 2008
    Report Date
    March 20, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    LWS
    PMA / PMN Number
    P9800023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PER OOS, THIS LEAD AND THE ICD WERE REMOVED BECAUSE THE LEAD HAD AN INSULATION BREAK LEAVING THE ICD BATTERY AT 32%.

    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 67 YR Hospitalization