BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX JT 45

    MDR report key: 2974000 · Received February 13, 2013

    Report

    Report Number
    1028232-2013-00270
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DTB
    PMA / PMN Number
    P950037
    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

    THIS LEAD WAS CAPPED AND REPLACED DURING A DEVICE CHANGE OUT BECAUSE THE PHYSICIAN FOUND IT OUTSIDE THE HEART IN THE LUMEN. THERE WERE NO ADVERSE PATIENT EVENTS REPORTED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64319 SELOX JT 45 PACER LEAD DTB BIOTRONIK SE & CO. KG 346369

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization