BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ISOFLEX S

    MDR report key: 4083607 · Received January 10, 2014

    Report

    Report Number
    2017865-2014-01321
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    October 17, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. CRMD
    Product Code
    DTB
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM FOR A SYNCOPAL EPISODE. LOSS OF VENTRICULAR CAPTURE WAS REPRODUCIBLE WITH POSITIONAL CHANGES. THE PHYSICIAN REVISED THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18137 ISOFLEX S PERMANENT PACEMAKER ELECTRODE DTB ST. JUDE MEDICAL, INC. CRMD 1646T/52

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention