BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX JT 53

    MDR report key: 6043626 · Received October 20, 2016

    Report

    Report Number
    1028232-2016-04206
    Event Type
    Injury
    Date Received
    October 20, 2016
    Date of Event
    October 12, 2016
    Report Date
    October 18, 2016
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    PMA / PMN Number
    P950037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    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.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    WE WERE PROVIDED WITH AN ADDITIONAL ANALYSIS. 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, AND REVIEW OF VERIFICATION AND VALIDATION TESTING OF THE ASSOCIATED MANUFACTURING AND STERILITY PROCESSES. THE MANUFACTURING PROCESS FOR THIS DEVICE WAS RE-INVESTIGATED. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS WHICH MIGHT BE RELATED TO AN ADVERSE CLINICAL OBSERVATION. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY, INCLUDING PACKAGING AND STERILIZATION. THE PRODUCT WAS STERILIZED BY ETO PER A VALIDATED METHOD DEMONSTRATED TO YIELD A STERILITY ASSURANCE LEVEL (SAL) OF 1 X 10-6 (REFERENCE VER-111-16-0995). THE STERILE BARRIER HAS BEEN DEMONSTRATED TO BE INTACT UP TO 46 MONTHS AFTER STORAGE IN REAL TIME AGING CONDITIONS, AS DETERMINED FOR PRODUCT WITH THE SAME PACKAGING AND STERILITY PARAMETERS (REFERENCE: VER-111-13-0356). IN SUMMARY, THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE REVIEW OF THE QUALITY DOCUMENTS CONFIRMED A REGULAR DEVICE MANUFACTURING. IT IS PRESUMED THAT IF THE STERILE BARRIER WAS INTACT UP TO THE TIME OF IMPLANT, STERILITY WOULD NOT BE COMPROMISED

    Description of Event or Problem · 1

    WE WERE NOTIFIED THAT THIS LEAD WAS IMPLANTED 42 DAYS AFTER THE EXPIRATION DATE OF 31-AUG-2016. NO PATIENT ADVERSE EVENTS ARE NOTED. THE LEAD REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695303 SELOX JT 53 PACER LEAD NVN BIOTRONIK SE & CO. KG 346368

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR