BEUDAMED
    FDA Adverse Event Death Summary report: N

    SETROX S 53

    MDR report key: 2072494 · Received April 22, 2011

    Report

    Report Number
    1028232-2011-00906
    Event Type
    Death
    Date Received
    April 22, 2011
    Date of Event
    March 13, 2011
    Report Date
    April 12, 2011
    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

    THIS PATIENT EXPIRED AROUND (B)(6) 2011; THE EXACT DATE OF DEATH IS UNKNOWN. PER THE PRIMARY CARE PHYSICIAN'S OFFICE, THIS PATIENT EXPIRED DUE TO CARDIAC ARREST.

    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 73 YR Death