BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SELOX JT 45

    MDR report key: 3812982 · Received May 15, 2014

    Report

    Report Number
    1028232-2014-01748
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    August 16, 2010
    Report Date
    April 25, 2014
    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
    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 RA LEAD WAS EXPLANTED AND REPLACED FOR AN UNKNOWN REASON. WE DO KNOW THAT THE PHYSICIAN EXPLANTED THE LV LEAD AT THE SAME TIME DUE TO DISLODGMENT BUT WE ARE UNABLE TO GET INFORMATION AS TO WHY THE RV AND RA LEADS WERE REMOVED. THERE ARE NO KNOWN COMPLAINTS AGAINST THIS LEAD. THIS LEAD WAS NOT RETURNED FOR ANALYSIS. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THIS FILE WILL BE UPDATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290338 SELOX JT 45 PACER LEAD NVN BIOTRONIK SE & CO. KG 346369

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization