BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2872114 · Received December 4, 2012

    Report

    Report Number
    1028232-2012-03151
    Event Type
    Injury
    Date Received
    December 4, 2012
    Date of Event
    November 19, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BIOTRONIK SE & CO KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THERE WAS A LEAD REVISION DONE DUE TO DISLODGEMENT. THIS LEAD REMAINS ACTIVELY IMPLANTED. THERE WERE NO ADVERSE PT EVENTS REPORTED. SHOULD ADDITIONAL INFO BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE & CO KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Hospitalization