BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 53

    MDR report key: 1954278 · Received December 13, 2010

    Report

    Report Number
    1028232-2010-02719
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DXY
    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

    THE LEAD HISTORICALLY HAS HAD IMPEDANCES BETWEEN 600-700 OHMS. SIX MONTHS AGO, THE IMPEDANCE WAS 1100 OHMS AND THERE WAS A NOTABLE INCREASE IN THRESHOLD. TODAY, THE IMPEDANCE IS GREATER THEN 3200 OHMS AND THERE IS NO CAPTURE AT MAXIMUM OUTPUT. AT THIS TIME, THE LEAD REMAINS IMPLANTED. ON (B)(6) 2010 - AS OF TODAY, IT IS UNK WHAT TYPE OF INTERVENTION, IF ANY, WILL E TAKEN TO CORRECT THE OBSERVED ISSUE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS EVENT WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SELOX ST 53 PACER LEAD DXY BIOTRONIK SE & CO. KG 346366

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Other