BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNOX SX 45-JBP

    MDR report key: 1080467 · Received July 21, 2008

    Report

    Report Number
    1028232-2008-00759
    Event Type
    Injury
    Date Received
    July 21, 2008
    Date of Event
    May 9, 2008
    Report Date
    June 18, 2008
    Manufacturer
    BIOTRONIK GMBH AND CO.
    Product Code
    DTB
    PMA / PMN Number
    K980869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    PER BIOTRONIK REPRESENTATIVE, THIS SYSTEM WAS REMOVED DUE TO INFECTION. PER THE OOS, THIS LEAD WAS REPLACED WITH A SELOX JT 45. THE INFECTED SYSTEM: PHILOS II DR, 75965732, MDR: 1028232-2008-00758; SYNOX SX 45-JBP, MDR: 1028232-2008-00759; SYNOX SX 53-BP, MDR: 1028232-2008-00760.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNOX SX 45-JBP PACER LEAD DTB BIOTRONIK GMBH AND CO. 120438

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization