BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNOX SX 45-JBP

    MDR report key: 1982267 · Received February 1, 2011

    Report

    Report Number
    1028232-2011-00239
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    December 7, 2010
    Report Date
    January 21, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    K980869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD WAS CAPPED DUE TO DISLODGEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization