BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX ST 60

    MDR report key: 1912662 · Received November 24, 2010

    Report

    Report Number
    1028232-2010-02619
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    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

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE ANALYSIS IS, THEREFORE, BASED ON THE INSPECTION OF THE QUALITY DOCUMENTS ACCOMPANYING 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

    PACEMAKER SYSTEM WAS IMPLANTED APPROXIMATELY SIX MONTHS AGO. THE VENTRICULAR BIPOLAR IMPEDANCE HAS DROPPED. THRESHOLD WAS 0.4 AT IMPLANT AND IS NOW 1.5 V. SENSING WAS 14.3 MV AT IMPLANT AND IS NOW 10 MV. IEGM SHOWS THE VENTRICULAR LEAD IS SENSING ATRIAL SIGNALS. AN X-RAY FOUND THIS LEAD TO HAVE DISLODGED. THE PATIENT IS SCHEDULED FOR A LEAD REVISION PROCEDURE WITHIN THE NEXT FEW WEEKS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other