BEUDAMED
    FDA Adverse Event Other Summary report: N

    KENTROX SL-S 65/16

    MDR report key: 682018 · Received March 2, 2006

    Report

    Report Number
    1028232-2006-00021
    Event Type
    Other
    Date Received
    March 2, 2006
    Date of Event
    August 16, 2005
    Report Date
    February 27, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    REPORTED 2/23/2006; PRODUCT WAS IMPLANTED WITH AN ICD SYSTEM THAT WAS REMOVED DUE TO INFECTION AND EROSION. OOS REPORT WAS COMPLETED FOR THE ICD BUT NOT THE LEAD.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other