BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELOX ST 60

    MDR report key: 2222390 · Received July 15, 2011

    Report

    Report Number
    1028232-2011-01553
    Event Type
    Malfunction
    Date Received
    July 15, 2011
    Report Date
    July 7, 2011
    Manufacturer
    BIOTRONIK SE & CO, KG
    Product Code
    NVZ
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    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

    AFTER AN IMPLANTATION TIME OF APPROXIMATELY 5 YEARS, NO CAPTURE WAS REPORTED. NO ADVERSE PATIENT SIDE EFFECTS HAVE BEEN REPORTED. NO EVENT OR EXPLANT DATE WAS PROVIDED. THIS LEAD WAS NOT RETURNED FOR ANALYSIS.

    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 UNK Other