BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2132199 · Received June 13, 2011

    Report

    Report Number
    1028232-2011-01262
    Event Type
    Injury
    Date Received
    June 13, 2011
    Date of Event
    May 27, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THIS LEAD BECAME DISLODGED DUE TO SEVERE TRICUSPID REGURGITATION. AFTER ATTEMPTING TO REPOSITION THIS LEAD UNSUCCESSFULLY, THE PHYSICIAN CHOSE TO REPLACE THIS LEAD WITH ANOTHER.

    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 75 YR Hospitalization