BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ISOFLEX S

    MDR report key: 4140657 · Received January 13, 2014

    Report

    Report Number
    2017865-2014-05781
    Event Type
    Malfunction
    Date Received
    January 13, 2014
    Date of Event
    October 11, 2012
    Manufacturer
    ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
    Product Code
    NVN
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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 LEAD WAS UNDERSENSING. THE DEVICE WAS REPROGRAMMED FROM DDD TO VVI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33942 ISOFLEX S NVN ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI 1624T/52

    Patients

    Seq Age Sex Outcome Treatment
    1