BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SETROX S 53

    MDR report key: 2933084 · Received January 23, 2013

    Report

    Report Number
    1028232-2013-00101
    Event Type
    Injury
    Date Received
    January 23, 2013
    Date of Event
    November 21, 2012
    Report Date
    January 14, 2013
    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 SYSTEM WAS EXPLANTED DUE TO ENDOCARDITIS ON (B)(6) 2012. THIS SYSTEM WAS RETAINED BY THE HOSPITAL. THERE ARE NO KNOWN COMPLAINTS ASSOCIATED WITH THE FUNCTIONALITY OF THIS DEVICE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILL WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33244 SETROX S 53 PACER LEAD NVZ BIOTRONIK SE& CO. KG 350974

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization