BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENDRIL STS

    MDR report key: 3925384 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08894
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    February 6, 2013
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    NVN
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE ATRIAL LEAD WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38281 TENDRIL STS NVN ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 2088TC/52

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1458Q/86 BPU028146| CD3249-40Q 7015867,| 7122Q/52 BKA014515,