BEUDAMED
    FDA Adverse Event Other Summary report: N

    SELOX JT 53

    MDR report key: 731116 · Received June 29, 2006

    Report

    Report Number
    1028232-2006-00107
    Event Type
    Other
    Date Received
    June 29, 2006
    Date of Event
    March 31, 2006
    Report Date
    April 17, 2006
    Manufacturer
    BIOTRONIK GMBH AND CO
    Product Code
    DTB
    PMA / PMN Number
    p950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    AN INTERNAL REVIEW REVEALED THAT THIS PRODUCT WAS REMOVED FOR INFECTION AND DISCARDED BY THE HOSPITAL. THIS DEVICE WAS PART OF A SYSTEM REMOVED FOR INFECTION. PLEASE REFERENCE LEXOS DR-T, SN: 79844240, MDR# 06-0050 FOR ADDITIONAL INFORMATION. A NEW SYSTEM WAS IMPLANTED AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX JT 53 BRADICARDIA LEAD DTB BIOTRONIK GMBH AND CO 346 366 *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization