BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SETROX S 45

    MDR report key: 3952888 · Received July 23, 2014

    Report

    Report Number
    1028232-2014-002669
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 19, 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
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    THIS PATIENT HAD AN AORTIC VALVE REPLACEMENT ON (B)(6) 2014. AFTER THIS PROCEDURE, HIGH THRESHOLDS AND CAPTURE ISSUES IN THE ATRIAL CHANNEL WERE NOTED. THESE PERSISTED FOR SEVERAL DAYS AND A CHEST X-RAY SHOWED THAT THE LEAD WAS NOT DISLODGED. ON (B)(6) 2014, THE PHYSICIAN OPENED THE POCKET TO TEST THE RA LEAD, WHICH HAD HIGH THRESHOLDS THROUGH THE ANALYZER AS WELL. THE PHYSICIAN CAPPED THIS LEAD AND REPLACED IT WITH A COMPETITIVE LEAD. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    430258 SETROX S 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 350973

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization