BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 3843169 · Received June 2, 2014

    Report

    Report Number
    1028232-2014-01794
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 5, 2014
    Report Date
    May 20, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OUS MDR - AFTER AN IMPLANTATION PERIOD OF ABOUT 33 MONTHS, AN IMPEDANCE INCREASE >2500 OHM AND THRESHOLD VALUES OVER [email protected] WERE REPORTED. THE LEAD IS ACTIVE AND IMPLANTED. THE PATIENT IS NOT DEPENDEND ON THE VENTRICULAR LEAD. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321250 SELOX ST 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization