BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZEPHYR XL DR

    MDR report key: 3915857 · Received January 15, 2014

    Report

    Report Number
    2017865-2014-08452
    Event Type
    Injury
    Date Received
    January 15, 2014
    Date of Event
    August 30, 2011
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    LWP
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS REC'D. 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. EVALUATIONS DESCRIPTION: ANALYSIS PERFORMED AFTER DOWNLOAD INDICATED THAT THE DEVICE EXHIBITED NORMAL DEVICE CHARACTERISTICS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION. THE SYSTEM WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39411 ZEPHYR XL DR IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 5826

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention