BEUDAMED
    FDA Adverse Event Summary report: N

    SETROX S 60

    MDR report key: 3061487 · Received April 16, 2013

    Report

    Report Number
    1028232-2013-00571
    Date Received
    April 16, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 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 DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS THEREFORE BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO THE CLINICAL OBSERVATION. IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING.

    Description of Event or Problem · 1

    A HIGH THRESHOLD WAS MEASURED IN THE VENTRICLE AT IN-CLINIC F/U. NO OTHER ANOMALIES WERE REPORTED FOR THE LEAD. THE PHYSICIAN PLANS TO REVISE THE LEAD TODAY. ON (B)(6) 2013, THE LOCAL REP WAS CONTACTED TO VERIFY LEAD DISPOSITION. SHE STATED THAT THIS LEAD REMAINS IMPLANTED, BUT THE ASSOCIATED DEVICE WAS EXPLANTED DUE TO ERI BEING TRIGGERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163847 SETROX S 60 PACER LEAD, PRODUCT CODDE NVN NVN BIOTRONIK SE & CO. KG 350975

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization