BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 3232152 · Received July 17, 2013

    Report

    Report Number
    1028232-2013-01940
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 24, 2013
    Report Date
    July 2, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED, INCLUDING A VISUAL AND AN ELECTRICAL INSPECTION. WITH REGARD TO THE ISSUES MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY IRREGULARITY. IN PARTICULAR, THE VALUES OF THE PARAMETERS MEASURED DURING THE ELECTRICAL ANALYSIS PROVED TO BE WITHIN THE TECHNICAL SPECIFICATIONS. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS LEAD WAS EXPLANTED DUE TO HIGH IMPEDANCES AND THRESHOLDS. AS THE PATIENT WAS IN A-FIB AND NO LONGER NEEDED, THE CHRONIC RA LEAD WAS REPOSITIONED FROM THE ATRIUM INTO THE RV TO REPLACE THIS LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332531 SELOX ST 60 PACER LEAD NVN BIOTRONIK SE & CO. KG 346367

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization