BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLUS MICRONY II

    MDR report key: 4191944 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-04563
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    April 19, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC.,CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    LWP
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFO PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. 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. EVAL: ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE PULSE GENERATOR EXHIBITED LOSS OF CAPTURE WHEN THE LEAD WAS CONNECTED. THE DEVICE WAS NOT IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    28806 SOLUS MICRONY II IMPLANTABLE PACEMAKER PULSE GENERATOR LWP ST. JUDE MEDICAL, INC.,CARDIAC RHYTHM MANAGEMENT DIVISI 2526T

    Patients

    Seq Age Sex Outcome Treatment
    1