BEUDAMED
    FDA Adverse Event Other Summary report: N

    SETROX S 53

    MDR report key: 1770346 · Received July 19, 2010

    Report

    Report Number
    1028232-2010-01537
    Event Type
    Other
    Date Received
    July 19, 2010
    Date of Event
    February 6, 2010
    Report Date
    June 29, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD FRACTURE WITH NO INTERVENTION.

    Description of Event or Problem · 1

    PER (B)(4) ADVERSE EVENT REPORT, IT WAS DISCOVERED THAT THIS LEAD WAS FRACTURED. THIS EVENT REMAINS UNRESOLVED AND, AS OF THIS REPORT, NO ACTION HAS BEEN TAKEN TO CORRECT THIS ISSUE. SHOULD ADDITIONAL INFO BECOME AVAILABLE, THIS EVENT 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 50 YR Other